20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

• ClinicalTrials.gov Identifier: NCT04382326
• Recruitment Status: Completed
• First Posted: May 11, 2020
• Results First Posted: December 6, 2023
• Last Update Posted: December 6, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Pneumococcal Disease
• Interventions: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine
• Enrollment: 1997

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 1997 participants were enrolled and assigned to receive 4 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13vPnC of which 6 participants were not vaccinated and 1991 were vaccinated with either 20vPnC or 13vPnC.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Period Title: Overall Study
Started	1001	987
Completed	821	799
Not Completed	180	188
Reason Not Completed
Adverse Event, not serious	1	2
Other	1	0
Withdrawal By Parent/Guardian	50	54
No Longer Meets Eligibility Criteria	50	44
Protocol Violation	29	23
Physician Decision	0	1
Lost to Follow-up	48	63
Adverse Event, non-fatal	1	1

Baseline Characteristics

Arm/Group Title		20vPnC	13vPnC	Total
Arm/Group Description		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Total of all reporting groups
Overall Number of Baseline Participants		1001	987	1988
Baseline Analysis Population Description		Safety population included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	1001 participants	987 participants	1988 participants
		65.9 (7.98)	65.6 (7.12)	65.8 (7.56)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1001 participants	987 participants	1988 participants
	Female	483 48.3%	482 48.8%	965 48.5%
	Male	518 51.7%	505 51.2%	1023 51.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1001 participants	987 participants	1988 participants
	Hispanic or Latino	312 31.2%	293 29.7%	605 30.4%
	Not Hispanic or Latino	661 66.0%	659 66.8%	1320 66.4%
	Unknown or Not Reported	28 2.8%	35 3.5%	63 3.2%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1001 participants	987 participants	1988 participants
	American Indian or Alaska Native	4 0.4%	3 0.3%	7 0.4%
	Asian	16 1.6%	16 1.6%	32 1.6%
	Native Hawaiian or Other Pacific Islander	2 0.2%	2 0.2%	4 0.2%
	Black or African American	110 11.0%	108 10.9%	218 11.0%
	White	754 75.3%	742 75.2%	1496 75.3%
	More than one race	68 6.8%	73 7.4%	141 7.1%
	Unknown or Not Reported	47 4.7%	43 4.4%	90 4.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Description	Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame	Within 7 days after Dose 1

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 1.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	993	974
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Any	25.5; (22.8 to 28.3)	24.6; (22.0 to 27.5)
Redness: Mild	21.5; (18.9 to 24.1)	22.3; (19.7 to 25.0)
Redness: Moderate	4.0; (2.9 to 5.4)	2.4; (1.5 to 3.5)
Redness: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)
Swelling: Any	16.4; (14.2 to 18.9)	18.8; (16.4 to 21.4)
Swelling: Mild	11.5; (9.6 to 13.6)	14.7; (12.5 to 17.1)
Swelling: Moderate	4.8; (3.6 to 6.4)	4.1; (2.9 to 5.6)
Swelling: Severe	0.1; (0.0 to 0.6)	0; (0.0 to 0.4)
Pain at the injection site: Any	49.1; (46.0 to 52.3)	45.3; (42.1 to 48.5)
Pain at the injection site: Mild	30.6; (27.8 to 33.6)	30.4; (27.5 to 33.4)
Pain at the injection site: Moderate	18.4; (16.1 to 21.0)	14.9; (12.7 to 17.3)
Pain at the injection site: Severe	0.1; (0.0 to 0.6)	0; (0.0 to 0.4)

2. Primary Outcome

Title	Percentage of Participants With Local Reaction Within 7 Days After Dose 2
Description	Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame	Within 7 Days After Dose 2

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 2.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	940	924
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Any	23.2; (20.5 to 26.0)	26.4; (23.6 to 29.4)
Redness: Mild	21.2; (18.6 to 23.9)	23.1; (20.4 to 25.9)
Redness: Moderate	2.0; (1.2 to 3.1)	3.4; (2.3 to 4.7)
Redness: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)
Swelling: Any	15.5; (13.3 to 18.0)	17.3; (14.9 to 19.9)
Swelling: Mild	11.5; (9.5 to 13.7)	13.5; (11.4 to 15.9)
Swelling: Moderate	4.0; (2.9 to 5.5)	3.8; (2.7 to 5.2)
Swelling: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)
Pain at the injection site: Any	44.0; (40.8 to 47.3)	41.7; (38.5 to 44.9)
Pain at the injection site: Mild	29.3; (26.4 to 32.3)	27.7; (24.8 to 30.7)
Pain at the injection site: Moderate	14.8; (12.6 to 17.2)	14.0; (11.8 to 16.4)
Pain at the injection site: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)

3. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description	Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame	Within 7 days after Dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 3.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	914	901
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Any	25.4; (22.6 to 28.3)	27.2; (24.3 to 30.2)
Redness: Mild	21.1; (18.5 to 23.9)	23.5; (20.8 to 26.4)
Redness: Moderate	4.3; (3.1 to 5.8)	3.7; (2.5 to 5.1)
Redness: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)
Swelling: Any	17.1; (14.7 to 19.7)	17.6; (15.2 to 20.3)
Swelling: Mild	12.5; (10.4 to 14.8)	13.8; (11.6 to 16.2)
Swelling: Moderate	4.6; (3.3 to 6.2)	3.8; (2.6 to 5.2)
Swelling: Severe	0; (0.0 to 0.4)	0.1; (0.0 to 0.6)
Pain at the injection site: Any	38.6; (35.5 to 41.9)	39.0; (35.8 to 42.2)
Pain at the injection site: Mild	25.7; (22.9 to 28.7)	25.5; (22.7 to 28.5)
Pain at the injection site: Moderate	12.9; (10.8 to 15.3)	13.4; (11.3 to 15.8)
Pain at the injection site: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.4)

4. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Description	Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Time Frame	Within 7 days after Dose 4

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	826	815
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Any	23.5; (20.6 to 26.5)	26.6; (23.6 to 29.8)
Redness: Mild	19.6; (17.0 to 22.5)	22.0; (19.2 to 25.0)
Redness: Moderate	3.9; (2.7 to 5.4)	4.7; (3.3 to 6.3)
Redness: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.5)
Swelling: Any	14.9; (12.5 to 17.5)	17.3; (14.8 to 20.1)
Swelling: Mild	10.7; (8.6 to 13.0)	13.6; (11.3 to 16.2)
Swelling: Moderate	4.2; (3.0 to 5.8)	3.7; (2.5 to 5.2)
Swelling: Severe	0; (0.0 to 0.4)	0; (0.0 to 0.5)
Pain at the injection site: Any	35.7; (32.4 to 39.1)	35.8; (32.5 to 39.2)
Pain at the injection site: Mild	24.1; (21.2 to 27.2)	27.1; (24.1 to 30.3)
Pain at the injection site: Moderate	11.3; (9.2 to 13.6)	8.7; (6.9 to 10.9)
Pain at the injection site: Severe	0.4; (0.1 to 1.1)	0; (0.0 to 0.5)

5. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description	Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame	Within 7 days after Dose 1

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 1.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	993	974
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=38.0 degree C	10.3; (8.5 to 12.3)	7.5; (5.9 to 9.3)
Fever: >=38.0 degree C to 38.4 degree C	7.3; (5.7 to 9.0)	6.3; (4.8 to 8.0)
Fever: >38.4 degree C to 38.9 degree C	2.2; (1.4 to 3.3)	0.9; (0.4 to 1.7)
Fever: >38.9 degree C to 40.0 degree C	0.7; (0.3 to 1.4)	0.3; (0.1 to 0.9)
Fever: >40.0 degree C	0.1; (0.0 to 0.6)	0; (0.0 to 0.4)
Decreased appetite: Any	24.4; (21.7 to 27.2)	23.9; (21.3 to 26.7)
Decreased appetite: Mild	14.5; (12.4 to 16.8)	16.1; (13.9 to 18.6)
Decreased appetite: Moderate	9.7; (7.9 to 11.7)	7.5; (5.9 to 9.3)
Decreased appetite: Severe	0.2; (0.0 to 0.7)	0.3; (0.1 to 0.9)
Drowsiness: Any	67.2; (64.2 to 70.1)	66.0; (62.9 to 69.0)
Drowsiness: Mild	50.2; (47.0 to 53.3)	49.3; (46.1 to 52.5)
Drowsiness: Moderate	16.1; (13.9 to 18.5)	15.6; (13.4 to 18.0)
Drowsiness: Severe	0.9; (0.4 to 1.7)	1.1; (0.6 to 2.0)
Irritability: Any	70.9; (68.0 to 73.7)	71.7; (68.7 to 74.5)
Irritability: Mild	23.4; (20.8 to 26.1)	21.6; (19.0 to 24.3)
Irritability: Moderate	43.0; (39.9 to 46.1)	46.2; (43.0 to 49.4)
Irritability: Severe	4.5; (3.3 to 6.0)	3.9; (2.8 to 5.3)
Use of antipyretic or pain medication	35.1; (32.2 to 38.2)	33.8; (30.8 to 36.8)

6. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Description	Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame	Within 7 days after Dose 2

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 2.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	940	924
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=38.0 degree C	17.3; (15.0 to 19.9)	16.3; (14.0 to 18.9)
Fever: >=38.0 degree C to 38.4 degree C	10.9; (8.9 to 13.0)	10.0; (8.1 to 12.1)
Fever: >38.4 degree C to 38.9 degree C	4.0; (2.9 to 5.5)	4.2; (3.0 to 5.7)
Fever: >38.9 degree C to 40.0 degree C	2.2; (1.4 to 3.4)	2.2; (1.3 to 3.3)
Fever: >40.0 degree C	0.2; (0.0 to 0.8)	0; (0.0 to 0.4)
Decreased appetite: Any	26.4; (23.6 to 29.3)	23.5; (20.8 to 26.4)
Decreased appetite: Mild	16.4; (14.1 to 18.9)	15.3; (13.0 to 17.7)
Decreased appetite: Moderate	9.8; (8.0 to 11.9)	7.7; (6.0 to 9.6)
Decreased appetite: Severe	0.2; (0.0 to 0.8)	0.5; (0.2 to 1.3)
Drowsiness: Any	54.7; (51.4 to 57.9)	55.6; (52.4 to 58.9)
Drowsiness: Mild	37.0; (33.9 to 40.2)	36.9; (33.8 to 40.1)
Drowsiness: Moderate	16.9; (14.6 to 19.5)	17.9; (15.4 to 20.5)
Drowsiness: Severe	0.7; (0.3 to 1.5)	0.9; (0.4 to 1.7)
Irritability: Any	71.6; (68.6 to 74.5)	68.8; (65.7 to 71.8)
Irritability: Mild	22.9; (20.2 to 25.7)	21.2; (18.6 to 24.0)
Irritability: Moderate	44.7; (41.5 to 47.9)	43.4; (40.2 to 46.7)
Irritability: Severe	4.0; (2.9 to 5.5)	4.2; (3.0 to 5.7)
Use of antipyretic or pain medication	40.7; (37.6 to 44.0)	41.0; (37.8 to 44.3)

7. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Description	Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame	Within 7 days after Dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 3.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	914	901
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=38.0 degree C	12.6; (10.5 to 14.9)	13.7; (11.5 to 16.1)
Fever: >=38.0 degree C to 38.4 degree C	7.7; (6.0 to 9.6)	7.9; (6.2 to 9.8)
Fever: >38.4 degree C to 38.9 degree C	3.4; (2.3 to 4.8)	3.9; (2.7 to 5.4)
Fever: >38.9 degree C to 40.0 degree C	1.4; (0.8 to 2.4)	1.9; (1.1 to 3.0)
Fever: >40.0 degree C	0.1; (0.0 to 0.6)	0; (0.0 to 0.4)
Decreased appetite: Any	20.6; (18.0 to 23.3)	22.4; (19.7 to 25.3)
Decreased appetite: Mild	13.5; (11.3 to 15.8)	13.9; (11.7 to 16.3)
Decreased appetite: Moderate	6.7; (5.1 to 8.5)	8.2; (6.5 to 10.2)
Decreased appetite: Severe	0.4; (0.1 to 1.1)	0.3; (0.1 to 1.0)
Drowsiness: Any	44.1; (40.8 to 47.4)	44.1; (40.8 to 47.4)
Drowsiness: Mild	31.1; (28.1 to 34.2)	30.1; (27.1 to 33.2)
Drowsiness: Moderate	12.5; (10.4 to 14.8)	13.1; (11.0 to 15.5)
Drowsiness: Severe	0.5; (0.2 to 1.3)	0.9; (0.4 to 1.7)
Irritability: Any	64.4; (61.2 to 67.5)	63.0; (59.8 to 66.2)
Irritability: Mild	25.2; (22.4 to 28.1)	21.6; (19.0 to 24.5)
Irritability: Moderate	37.5; (34.4 to 40.8)	39.2; (36.0 to 42.5)
Irritability: Severe	1.8; (1.0 to 2.8)	2.2; (1.4 to 3.4)
Use of antipyretic/pain medication	36.3; (33.2 to 39.5)	36.1; (32.9 to 39.3)

8. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Description	Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever was defined as temperature >= 38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time Frame	Within 7 days after Dose 4

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	826	815
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >= 38.0 degree C	14.5; (12.2 to 17.1)	14.0; (11.7 to 16.6)
Fever: >=38.0 degree C to 38.4 degree C	6.5; (4.9 to 8.4)	7.7; (6.0 to 9.8)
Fever: >38.4 degree C to 38.9 degree C	5.1; (3.7 to 6.8)	3.2; (2.1 to 4.6)
Fever: >38.9 degree C to 40.0 degree C	2.7; (1.7 to 4.0)	2.9; (1.9 to 4.4)
Fever: >40.0 degree C	0.2; (0.0 to 0.9)	0.1; (0.0 to 0.7)
Decreased appetite: Any	24.8; (21.9 to 27.9)	25.2; (22.2 to 28.3)
Decreased appetite: Mild	15.9; (13.4 to 18.5)	16.1; (13.6 to 18.8)
Decreased appetite: Moderate	8.6; (6.8 to 10.7)	8.3; (6.5 to 10.5)
Decreased appetite: Severe	0.4; (0.1 to 1.1)	0.7; (0.3 to 1.6)
Drowsiness: Any	39.5; (36.1 to 42.9)	39.5; (36.1 to 43.0)
Drowsiness: Mild	27.8; (24.8 to 31.0)	28.2; (25.2 to 31.4)
Drowsiness: Moderate	11.0; (9.0 to 13.4)	10.7; (8.6 to 13.0)
Drowsiness: Severe	0.6; (0.2 to 1.4)	0.6; (0.2 to 1.4)
Irritability: Any	61.0; (57.6 to 64.4)	61.1; (57.7 to 64.5)
Irritability: Mild	23.4; (20.5 to 26.4)	21.8; (19.0 to 24.8)
Irritability: Moderate	35.0; (31.7 to 38.3)	37.9; (34.6 to 41.3)
Irritability: Severe	2.7; (1.7 to 4.0)	1.3; (0.7 to 2.4)
Use of antipyretic/pain medication	37.5; (34.2 to 40.9)	36.7; (33.4 to 40.1)

9. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Description	An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events.
Time Frame	From Dose 1 to 1 Month after Dose 3

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	1001	987
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	36.6; (33.6 to 39.6)	39.4; (36.3 to 42.5)

10. Primary Outcome

Title	Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
Description	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events.
Time Frame	From Dose 4 to 1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 4 and had safety follow up after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	853	841
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	15.1; (12.8 to 17.7)	15.0; (12.6 to 17.6)

11. Primary Outcome

Title	Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4
Description	A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Time Frame	From Dose 1 to 6 months following Dose 4

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	1001	987
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	4.5; (3.3 to 6.0)	3.1; (2.1 to 4.4)

12. Primary Outcome

Title	Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4
Description	An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Time Frame	From Dose 1 to 6 months following Dose 4

Outcome Measure Data

Analysis Population Description

Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	1001	987
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	5.0; (3.7 to 6.5)	5.9; (4.5 to 7.5)

13. Primary Outcome

Title	Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Description	Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time Frame	1 month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		833	803
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Serotype 1	Number Analyzed	833 participants	802 participants
		79.8; (76.9 to 82.5)	88.4; (86.0 to 90.5)
Serotype 3	Number Analyzed	833 participants	802 participants
		52.1; (48.6 to 55.5)	67.6; (64.2 to 70.8)
Serotype 4	Number Analyzed	833 participants	802 participants
		79.7; (76.8 to 82.4)	88.2; (85.7 to 90.3)
Serotype 5	Number Analyzed	833 participants	802 participants
		82.5; (79.7 to 85.0)	86.8; (84.2 to 89.1)
Serotype 6A	Number Analyzed	833 participants	802 participants
		93.5; (91.6 to 95.1)	95.9; (94.3 to 97.2)
Serotype 6B	Number Analyzed	831 participants	801 participants
		88.3; (85.9 to 90.4)	92.4; (90.3 to 94.1)
Serotype 7F	Number Analyzed	833 participants	802 participants
		96.6; (95.2 to 97.8)	97.6; (96.3 to 98.6)
Serotype 9V	Number Analyzed	833 participants	802 participants
		81.9; (79.1 to 84.4)	89.8; (87.5 to 91.8)
Serotype 14	Number Analyzed	832 participants	802 participants
		93.4; (91.5 to 95.0)	94.1; (92.3 to 95.7)
Serotype 18C	Number Analyzed	833 participants	802 participants
		92.6; (90.6 to 94.2)	93.1; (91.2 to 94.8)
Serotype 19A	Number Analyzed	833 participants	802 participants
		97.1; (95.7 to 98.1)	98.1; (96.9 to 98.9)
Serotype 19F	Number Analyzed	833 participants	802 participants
		96.9; (95.5 to 98.0)	96.6; (95.1 to 97.8)
Serotype 23F	Number Analyzed	833 participants	802 participants
		77.9; (74.9 to 80.7)	85.5; (82.9 to 87.9)
Serotype 8	Number Analyzed	833 participants	803 participants
		96.8; (95.3 to 97.9)	85.5; (82.9 to 87.9)
Serotype 10A	Number Analyzed	833 participants	803 participants
		82.2; (79.5 to 84.8)	85.5; (82.9 to 87.9)
Serotype 11A	Number Analyzed	833 participants	803 participants
		92.7; (90.7 to 94.4)	85.5; (82.9 to 87.9)
Serotype 12F	Number Analyzed	833 participants	803 participants
		67.5; (64.2 to 70.6)	85.5; (82.9 to 87.9)
Serotype 15B	Number Analyzed	833 participants	803 participants
		98.2; (97.0 to 99.0)	85.5; (82.9 to 87.9)
Serotype 22F	Number Analyzed	833 participants	803 participants
		98.3; (97.2 to 99.1)	85.5; (82.9 to 87.9)
Serotype 33F	Number Analyzed	833 participants	802 participants
		86.7; (84.2 to 88.9)	85.5; (82.9 to 87.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-8.6
	Confidence Interval	(2-Sided) 95%; -12.1 to -5.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-15.5
	Confidence Interval	(2-Sided) 95%; -20.1 to -10.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-8.4
	Confidence Interval	(2-Sided) 95%; -12.0 to -4.9
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-4.3
	Confidence Interval	(2-Sided) 95%; -7.8 to -0.8
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -4.6 to -0.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-4.1
	Confidence Interval	(2-Sided) 95%; -7.0 to -1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.7 to 0.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-7.9
	Confidence Interval	(2-Sided) 95%; -11.3 to -4.6
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -3.1 to 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -3.1 to 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.6 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -1.5 to 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-7.6
	Confidence Interval	(2-Sided) 95%; -11.4 to -3.9
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	11.2
	Confidence Interval	(2-Sided) 95%; 8.6 to 14.0
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-3.3
	Confidence Interval	(2-Sided) 95%; -6.9 to 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	7.1
	Confidence Interval	95%; 4.2 to 10.2
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	-18.1
	Confidence Interval	(2-Sided) 95%; -22.1 to -14.0
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 95%; 10.2 to 15.4
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	12.8
	Confidence Interval	(2-Sided) 95%; 10.3 to 15.5
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	percentage difference
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -2.2 to 4.5
	Estimation Comments	[Not Specified]

14. Primary Outcome

Title	Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4
Description	Concentrations of anticapsular IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in all participants at 1 month after Dose 4 using the Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ was set to 0.5*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
Time Frame	From Dose 1 to 6 months following Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 4 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		755	745
Geometric Mean (95% Confidence Interval); Unit of Measure: microgram per milliliter (μg/mL)
Serotype 1	Number Analyzed	755 participants	744 participants
		1.47; (1.37 to 1.57)	2.12; (1.97 to 2.27)
Serotype 3	Number Analyzed	755 participants	745 participants
		0.56; (0.53 to 0.60)	0.85; (0.80 to 0.90)
Serotype 4	Number Analyzed	754 participants	745 participants
		3.77; (3.52 to 4.04)	4.84; (4.50 to 5.22)
Serotype 5	Number Analyzed	755 participants	745 participants
		1.87; (1.74 to 2.00)	2.51; (2.33 to 2.70)
Serotype 6A	Number Analyzed	755 participants	745 participants
		9.01; (8.45 to 9.61)	11.69; (10.91 to 12.53)
Serotype 6B	Number Analyzed	753 participants	744 participants
		4.01; (3.70 to 4.35)	5.74; (5.27 to 6.24)
Serotype 7F	Number Analyzed	755 participants	745 participants
		3.91; (3.70 to 4.35)	5.18; (4.88 to 5.49)
Serotype 9V	Number Analyzed	755 participants	744 participants
		3.44; (3.23 to 3.67)	4.30; (4.02 to 4.59)
Serotype 14	Number Analyzed	755 participants	745 participants
		5.68; (5.27 to 6.12)	6.34; (5.88 to 6.83)
Serotype 18C	Number Analyzed	755 participants	745 participants
		3.46; (3.24 to 3.70)	4.69; (4.34 to 5.05)
Serotype 19A	Number Analyzed	754 participants	745 participants
		3.53; (3.30 to 3.77)	4.13; (3.84 to 4.45)
Serotype 19F	Number Analyzed	755 participants	745 participants
		5.01; (4.68 to 5.36)	5.79; (5.36 to 6.25)
Serotype 23F	Number Analyzed	755 participants	745 participants
		3.95; (3.63 to 4.31)	6.18; (5.66 to 6.75)
Serotype 8	Number Analyzed	755 participants	720 participants
		3.97; (3.73 to 4.22)	0.03; (0.03 to 0.04)
Serotype 10A	Number Analyzed	755 participants	745 participants
		6.22; (5.75 to 6.72)	0.01; (0.01 to 0.01)
Serotype 11A	Number Analyzed	755 participants	745 participants
		3.53; (3.31 to 3.78)	0.02; (0.02 to 0.02)
Serotype 12F	Number Analyzed	755 participants	745 participants
		1.85; (1.73 to 1.99)	0.01; (0.01 to 0.01)
Serotype 15B	Number Analyzed	755 participants	745 participants
		12.59; (11.78 to 13.45)	0.02; (0.02 to 0.03)
Serotype 22F	Number Analyzed	755 participants	745 participants
		10.60; (9.92 to 11.33)	0.00; (0.00 to 0.01)
Serotype 33F	Number Analyzed	755 participants	745 participants
		9.31; (8.71 to 9.96)	0.01; (0.01 to 0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.76
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.61 to 0.73
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.78
	Confidence Interval	95%; 0.70 to 0.86
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.85
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.79
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.80
	Confidence Interval	95%; 0.73 to 0.88
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.00
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.74
	Confidence Interval	95%; 0.67 to 0.82
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.77 to 0.94
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 95%; 0.78 to 0.96
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.87
	Confidence Interval	(2-Sided) 95%; 1.71 to 2.06
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	2.94
	Confidence Interval	95%; 2.64 to 3.26
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.67
	Confidence Interval	(2-Sided) 95%; 1.51 to 1.84
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.88
	Confidence Interval	95%; 0.79 to 0.97
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	5.95
	Confidence Interval	95%; 5.39 to 6.55
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	5.01
	Confidence Interval	95%; 4.54 to 5.52
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	4.40
	Confidence Interval	(2-Sided) 95%; 3.99 to 4.85
	Estimation Comments	[Not Specified]

15. Primary Outcome

Title	Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3
Description	Concentration of antibody to diphtheria toxoid (predefined level ≥0.1 IU/mL), tetanus toxoid (predefined level ≥0.1 IU/mL), IgG antibodies to pertussis antigens (pertussis toxin, filamentous hemagglutinin and pertactin, each with the predefined level as the 5th percentile observed in the 13vPnC group), hepatitis B antibody (in milli-international units per mL [mIU/mL]) (predefined level ≥10 mIU/mL), neutralizing antibody (NA) titers to poliovirus types 1, 2, and 3 (predefined level NA titer ≥1:8), Haemophilus influenzae type b (Hib) (≥0.15 μg/mL) were determined on subsets of sera collected at the immunogenicity time point 1 month after Dose 3. The antibody levels were measured by a validated multiplex Luminex immunoassay. The concomitant immune responses were measured on random subsets.
Time Frame	1 month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, had no major protocol deviations. "Number of Participants Analyzed"=participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid assay results for the specified antigen at 1 month after Dose 3.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		833	803
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Diphtheria	Number Analyzed	370 participants	363 participants
		93.5; (90.5 to 95.8)	97.8; (95.7 to 99.0)
Tetanus	Number Analyzed	370 participants	363 participants
		99.7; (98.5 to 100.0)	99.4; (98.0 to 99.9)
Pertussis (PT)	Number Analyzed	370 participants	363 participants
		94.9; (92.1 to 96.9)	95.0; (92.3 to 97.0)
Pertussis (FHA)	Number Analyzed	370 participants	363 participants
		95.7; (93.1 to 97.5)	95.0; (92.3 to 97.0)
Pertussis (PRN)	Number Analyzed	370 participants	363 participants
		93.8; (90.8 to 96.0)	95.0; (92.3 to 97.0)
hepatitis B surface antigen (HBsAg)	Number Analyzed	118 participants	127 participants
		100.0; (96.9 to 100.0)	100.0; (97.1 to 100.0)
Poliovirus (Type 1)	Number Analyzed	111 participants	117 participants
		100.0; (96.7 to 100.0)	100.0; (96.9 to 100.0)
Poliovirus (Type 2)	Number Analyzed	115 participants	120 participants
		100.0; (96.8 to 100.0)	99.2; (95.4 to 100.0)
Poliovirus (Type 3)	Number Analyzed	115 participants	120 participants
		100.0; (96.8 to 100.0)	100.0; (97.0 to 100.0)
Hib ≥0.15 μg/mL	Number Analyzed	124 participants	125 participants
		100.0; (97.1 to 100.0)	100.0; (97.1 to 100.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-4.3
	Confidence Interval	(2-Sided) 95%; -7.5 to -1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.2
	Confidence Interval	95%; -3.5 to 3.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.6
	Confidence Interval	95%; -2.5 to 3.9
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-1.3
	Confidence Interval	95%; -4.7 to 2.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	95%; -3.2 to 2.9
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	95%; -3.4 to 3.2
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.8
	Confidence Interval	95%; -2.4 to 4.6
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	95%; -3.2 to 3.1
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -3.0 to 3.0
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3
Description	Pneumococcal IgG antibody against each of the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F) was measured using direct binding Luminex assay. Results were expressed as IgG concentrations. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5*LLOQ.GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
Time Frame	1 month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		833	803
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
Serotype 1	Number Analyzed	833 participants	802 participants
		0.74; (0.70 to 0.79)	1.14; (1.06 to 1.22)
Serotype 3	Number Analyzed	833 participants	802 participants
		0.36; (0.33 to 0.38)	0.51; (0.48 to 0.55)
Serotype 4	Number Analyzed	833 participants	802 participants
		0.75; (0.70 to 0.81)	1.08; (1.00 to 1.17)
Serotype 5	Number Analyzed	833 participants	802 participants
		0.66; (0.61 to 0.71)	0.96; (0.88 to 1.04)
Serotype 6A	Number Analyzed	833 participants	802 participants
		1.95; (1.81 to 2.10)	2.69; (2.48 to 2.92)
Serotype 6B	Number Analyzed	831 participants	801 participants
		0.61; (0.55 to 0.68)	1.02; (0.91 to 1.14)
Serotype 7F	Number Analyzed	833 participants	802 participants
		1.71; (1.62 to 1.81)	2.29; (2.16 to 2.43)
Serotype 9V	Number Analyzed	833 participants	802 participants
		0.87; (0.81 to 0.93)	1.21; (1.12 to 1.30)
Serotype 14	Number Analyzed	832 participants	802 participants
		2.16; (2.01 to 2.33)	2.72; (2.51 to 2.95)
Serotype 18C	Number Analyzed	833 participants	802 participants
		1.31; (1.23 to 1.39)	1.71; (1.59 to 1.84)
Serotype 19A	Number Analyzed	833 participants	802 participants
		0.72; (0.67 to 0.76)	0.91; (0.85 to 0.97)
Serotype 19F	Number Analyzed	833 participants	802 participants
		1.59; (1.50 to 1.67)	2.00; (1.88 to 2.12)
Serotype 23F	Number Analyzed	833 participants	802 participants
		0.82; (0.75 to 0.90)	1.25; (1.14 to 1.37)
Serotype 8	Number Analyzed	833 participants	794 participants
		1.80; (1.70 to 1.91)	0.02; (0.02 to 0.02)
Serotype 10A	Number Analyzed	833 participants	803 participants
		1.21; (1.09 to 1.33)	0.01; (0.01 to 0.01)
Serotype 11A	Number Analyzed	833 participants	803 participants
		1.39; (1.30 to 1.48)	0.02; (0.01 to 0.02)
Serotype 12F	Number Analyzed	833 participants	803 participants
		0.55; (0.50 to 0.60)	0.01; (0.01 to 0.01)
Serotype 15B	Number Analyzed	833 participants	803 participants
		4.40; (4.11 to 4.71)	0.03; (0.02 to 0.03)
Serotype 22F	Number Analyzed	833 participants	803 participants
		3.71; (3.45 to 3.99)	0.01; (0.00 to 0.01)
Serotype 33F	Number Analyzed	833 participants	802 participants
		1.49; (1.36 to 1.64)	0.02; (0.01 to 0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratios
	Estimated Value	0.65
	Confidence Interval	(2-Sided) 95%; 0.59 to 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.76
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.70
	Confidence Interval	95%; 0.63 to 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.69
	Confidence Interval	95%; 0.61 to 0.77
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.72
	Confidence Interval	95%; 0.65 to 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.75
	Confidence Interval	95%; 0.69 to 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.80
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.79
	Confidence Interval	95%; 0.71 to 0.89
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.77
	Confidence Interval	95%; 0.70 to 0.84
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95%; 0.72 to 0.86
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.79
	Confidence Interval	95%; 0.73 to 0.86
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.75
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.98
	Confidence Interval	95%; 1.81 to 2.16
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.32
	Confidence Interval	95%; 1.18 to 1.49
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.52
	Confidence Interval	95%; 1.39 to 1.67
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	0.60
	Confidence Interval	95%; 0.54 to 0.67
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	4.82
	Confidence Interval	(2-Sided) 95%; 4.39 to 5.30
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	4.06
	Confidence Interval	95%; 3.68 to 4.48
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	Geometric Mean Ratio
	Estimated Value	1.64
	Confidence Interval	95%; 1.46 to 1.83
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4
Description	Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per mL (mcg/mL), for serotype 5: >=0.23 mcg/mL, for serotype 6B: >=0.10 mcg/mL and for serotype 19A: >=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses as randomized, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations. "Number of Participants Analyzed"=participants in Dose 4 evaluable immunogenicity population, "Number Analyzed" = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		755	745
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Serotype 1	Number Analyzed	755 participants	744 participants
		94.3; (92.4 to 95.8)	97.2; (95.7 to 98.2)
Serotype 3	Number Analyzed	755 participants	745 participants
		73.6; (70.3 to 76.8)	85.8; (83.1 to 88.2)
Serotype 4	Number Analyzed	754 participants	745 participants
		98.9; (97.9 to 99.5)	99.1; (98.1 to 99.6)
Serotype 5	Number Analyzed	755 participants	745 participants
		97.9; (96.6 to 98.8)	97.7; (96.4 to 98.7)
Serotype 6A	Number Analyzed	755 participants	745 participants
		99.5; (98.6 to 99.9)	99.7; (99.0 to 100.0)
Serotype 6B	Number Analyzed	753 participants	744 participants
		99.1; (98.1 to 99.6)	99.5; (98.6 to 99.9)
Serotype 7F	Number Analyzed	755 participants	745 participants
		99.5; (98.6 to 99.9)	99.9; (99.3 to 100.0)
Serotype 9V	Number Analyzed	755 participants	744 participants
		98.5; (97.4 to 99.3)	98.9; (97.9 to 99.5)
Serotype 14	Number Analyzed	755 participants	745 participants
		98.9; (97.9 to 99.5)	99.5; (98.6 to 99.9)
Serotype 18C	Number Analyzed	755 participants	745 participants
		98.9; (97.9 to 99.5)	99.5; (98.6 to 99.9)
Serotype 19A	Number Analyzed	754 participants	745 participants
		99.9; (99.3 to 100.0)	99.7; (99.0 to 100.0)
Serotype 19F	Number Analyzed	755 participants	745 participants
		98.8; (97.7 to 99.5)	98.9; (97.9 to 99.5)
Serotype 23F	Number Analyzed	755 participants	745 participants
		97.2; (95.8 to 98.3)	98.1; (96.9 to 99.0)
Serotype 8	Number Analyzed	755 participants	744 participants
		99.5; (98.6 to 99.9)	4.7; (3.3 to 6.5)
Serotype 10A	Number Analyzed	755 participants	744 participants
		97.7; (96.4 to 98.7)	2.0; (1.1 to 3.3)
Serotype 11A	Number Analyzed	755 participants	744 participants
		98.8; (97.7 to 99.5)	4.2; (2.8 to 5.9)
Serotype 12F	Number Analyzed	755 participants	744 participants
		95.2; (93.5 to 96.6)	0.3; (0.0 to 1.0)
Serotype 15B	Number Analyzed	755 participants	744 participants
		99.7; (99.0 to 100.0)	4.6; (3.2 to 6.3)
Serotype 22F	Number Analyzed	755 participants	744 participants
		99.6; (98.8 to 99.9)	1.5; (0.7 to 2.6)
Serotype 33F	Number Analyzed	755 participants	744 participants
		99.5; (98.6 to 99.9)	1.7; (0.9 to 3.0)

18. Secondary Outcome

Title	Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3
Description	OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomized subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 3.
Time Frame	1 month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, had no protocol deviations. "Number of Participants Analyzed" = Dose 3 evaluable immunogenicity populations. "Number Analyzed" = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 3.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		833	803
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serotype 1	Number Analyzed	103 participants	98 participants
		26; (21 to 33)	34; (27 to 42)
Serotype 3	Number Analyzed	105 participants	97 participants
		51; (43 to 61)	63; (53 to 76)
Serotype 4	Number Analyzed	97 participants	90 participants
		339; (252 to 455)	280; (207 to 378)
Serotype 5	Number Analyzed	103 participants	98 participants
		32; (27 to 39)	39; (32 to 47)
Serotype 6A	Number Analyzed	104 participants	96 participants
		910; (763 to 1084)	936; (757 to 1156)
Serotype 6B	Number Analyzed	99 participants	91 participants
		318; (242 to 419)	516; (409 to 651)
Serotype 7F	Number Analyzed	91 participants	87 participants
		1222; (1020 to 1465)	1149; (926 to 1424)
Serotype 9V	Number Analyzed	94 participants	87 participants
		661; (482 to 906)	594; (421 to 838)
Serotype 14	Number Analyzed	103 participants	97 participants
		415; (323 to 535)	420; (330 to 535)
Serotype 18C	Number Analyzed	95 participants	87 participants
		1153; (910 to 1460)	996; (754 to 1317)
Serotype 19A	Number Analyzed	93 participants	84 participants
		108; (78 to 149)	109; (79 to 151)
Serotype 19F	Number Analyzed	102 participants	97 participants
		84; (67 to 105)	116; (90 to 149)
Serotype 23F	Number Analyzed	96 participants	86 participants
		255; (186 to 350)	295; (215 to 406)
Serotype 8	Number Analyzed	100 participants	112 participants
		665; (503 to 880)	18; (17 to 20)
Serotype 10A	Number Analyzed	101 participants	109 participants
		2558; (1869 to 3501)	37; (33 to 42)
Serotype 11A	Number Analyzed	100 participants	108 participants
		289; (212 to 395)	50; (46 to 55)
Serotype 12F	Number Analyzed	92 participants	110 participants
		7677; (5952 to 9901)	28; (24 to 33)
Serotype 15B	Number Analyzed	97 participants	110 participants
		1560; (1090 to 2233)	18; (16 to 22)
Serotype 22F	Number Analyzed	97 participants	113 participants
		6797; (5170 to 8936)	9; (9 to 9)
Serotype 33F	Number Analyzed	85 participants	111 participants
		7388; (4803 to 11365)	198; (177 to 220)

19. Secondary Outcome

Title	Serotype-specific OPA GMTs at 1 Month After Dose 4
Description	OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomized subsets of participants at 1 month after Dose 4. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. OPA titers were determined in randomized subsets of participants at 1 month after Dose 4.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. "Number of Participants Analyzed" = Dose 4 evaluable immunogenicity populations. "Number Analyzed" = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 4.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		755	745
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serotype 1	Number Analyzed	94 participants	91 participants
		36; (27 to 48)	66; (50 to 87)
Serotype 3	Number Analyzed	92 participants	88 participants
		62; (49 to 78)	102; (86 to 120)
Serotype 4	Number Analyzed	85 participants	82 participants
		621; (435 to 887)	961; (714 to 1294)
Serotype 5	Number Analyzed	94 participants	91 participants
		55; (45 to 67)	69; (54 to 87)
Serotype 6A	Number Analyzed	93 participants	91 participants
		1384; (1092 to 1753)	1767; (1329 to 2348)
Serotype 6B	Number Analyzed	92 participants	88 participants
		666; (489 to 906)	1211; (861 to 1703)
Serotype 7F	Number Analyzed	84 participants	81 participants
		2022; (1673 to 2444)	2099; (1741 to 2531)
Serotype 9V	Number Analyzed	85 participants	79 participants
		2609; (1913 to 3558)	3210; (2500 to 4123)
Serotype 14	Number Analyzed	92 participants	91 participants
		667; (523 to 850)	593; (462 to 761)
Serotype 18C	Number Analyzed	84 participants	83 participants
		1973; (1472 to 2643)	2425; (1914 to 3072)
Serotype 19A	Number Analyzed	85 participants	78 participants
		844; (622 to 1145)	1357; (1007 to 1829)
Serotype 19F	Number Analyzed	93 participants	91 participants
		246; (179 to 337)	373; (272 to 513)
Serotype 23F	Number Analyzed	84 participants	77 participants
		827; (554 to 1235)	1532; (1118 to 2100)
Serotype 8	Number Analyzed	89 participants	97 participants
		1228; (901 to 1673)	26; (21 to 31)
Serotype 10A	Number Analyzed	99 participants	102 participants
		3674; (2746 to 4916)	57; (44 to 74)
Serotype 11A	Number Analyzed	90 participants	89 participants
		2728; (1975 to 3768)	69; (53 to 89)
Serotype 12F	Number Analyzed	86 participants	103 participants
		9320; (7037 to 12343)	31; (26 to 37)
Serotype 15B	Number Analyzed	92 participants	100 participants
		3035; (2138 to 4308)	23; (17 to 30)
Serotype 22F	Number Analyzed	86 participants	101 participants
		11077; (7956 to 15422)	15; (11 to 20)
Serotype 33F	Number Analyzed	80 participants	97 participants
		19216; (13193 to 27990)	363; (292 to 451)

20. Secondary Outcome

Title	Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4
Description	GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 were reported from Dose 3 evaluable immunogenicity participant.
Time Frame	1 month after Dose 3 to before Dose 4

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses as randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 3 evaluable immunogenicity population; "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		758	733
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	758 participants	733 participants
		0.3; (0.3 to 0.3)	0.3; (0.2 to 0.3)
Serotype 3	Number Analyzed	758 participants	733 participants
		0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)
Serotype 4	Number Analyzed	758 participants	733 participants
		0.3; (0.3 to 0.4)	0.3; (0.3 to 0.3)
Serotype 5	Number Analyzed	758 participants	733 participants
		0.3; (0.3 to 0.3)	0.3; (0.3 to 0.3)
Serotype 6A	Number Analyzed	758 participants	732 participants
		0.3; (0.3 to 0.3)	0.3; (0.3 to 0.3)
Serotype 6B	Number Analyzed	754 participants	730 participants
		0.4; (0.4 to 0.4)	0.3; (0.3 to 0.3)
Serotype 7F	Number Analyzed	758 participants	733 participants
		0.4; (0.4 to 0.6)	0.4; (0.3 to 0.4)
Serotype 9V	Number Analyzed	758 participants	733 participants
		0.3; (0.3 to 0.4)	0.3; (0.3 to 0.3)
Serotype 14	Number Analyzed	757 participants	733 participants
		0.5; (0.4 to 0.5)	0.5; (0.4 to 0.5)
Serotype 18C	Number Analyzed	758 participants	733 participants
		0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)
Serotype 19A	Number Analyzed	757 participants	733 participants
		0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)
Serotype 19F	Number Analyzed	758 participants	733 participants
		0.2; (0.2 to 0.3)	0.2; (0.2 to 0.2)
Serotype 23F	Number Analyzed	758 participants	733 participants
		0.3; (0.3 to 0.3)	0.3; (0.2 to 0.3)
Serotype 8	Number Analyzed	758 participants	706 participants
		0.2; (0.2 to 0.3)	1.4; (1.3 to 1.5)
Serotype 10A	Number Analyzed	758 participants	732 participants
		0.7; (0.6 to 0.7)	0.9; (0.9 to 1.0)
Serotype 11A	Number Analyzed	758 participants	732 participants
		0.3; (0.2 to 0.3)	1.1; (1.0 to 1.2)
Serotype 12F	Number Analyzed	758 participants	732 participants
		0.3; (0.3 to 0.4)	1.0; (1.0 to 1.1)
Serotype 15B	Number Analyzed	758 participants	732 participants
		0.4; (0.3 to 0.4)	0.8; (0.7 to 0.8)
Serotype 22F	Number Analyzed	758 participants	732 participants
		0.3; (0.3 to 0.4)	0.8; (0.7 to 0.9)
Serotype 33F	Number Analyzed	758 participants	731 participants
		0.7; (0.7 to 0.8)	0.8; (0.7 to 0.8)

21. Secondary Outcome

Title	Serotype-specific IgG GMFRs From 1 Month Before to 1 Month After Dose 4
Description	GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month before Dose 4 to 1 month after Dose 4 were reported from Dose 4 evaluable immunogenicity participants.
Time Frame	From 1 month before to 1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses as randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, and had no major protocol deviations. "Number of Participants Analyzed"= participants in Dose 4 evaluable immunogenicity population; "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		732	721
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	732 participants	720 participants
		7.3; (6.9 to 7.8)	7.1; (6.7 to 7.6)
Serotype 3	Number Analyzed	732 participants	721 participants
		8.5; (7.9 to 9.1)	9.0; (8.4 to 9.6)
Serotype 4	Number Analyzed	731 participants	721 participants
		15.4; (14.3 to 16.6)	14.2; (13.1 to 15.3)
Serotype 6A	Number Analyzed	732 participants	720 participants
		15.2; (14.3 to 16.2)	14.5; (13.1 to 15.3)
Serotype 6B	Number Analyzed	727 participants	718 participants
		18.0; (16.8 to 19.3)	17.0; (15.8 to 18.2)
Serotype 7F	Number Analyzed	732 participants	721 participants
		6.0; (5.7 to 6.3)	6.4; (6.0 to 6.8)
Serotype 9V	Number Analyzed	732 participants	720 participants
		11.8; (11.1 to 12.6)	11.2; (10.5 to 11.9)
Serotype 14	Number Analyzed	732 participants	721 participants
		5.9; (5.4 to 6.3)	5.0; (4.6 to 5.3)
Serotype 5	Number Analyzed	732 participants	721 participants
		8.9; (8.4 to 9.5)	8.5; (8.0 to 9.0)
Serotype 18C	Number Analyzed	732 participants	721 participants
		11.3; (10.6 to 12.0)	11.4; (10.7 to 12.1)
Serotype 19A	Number Analyzed	731 participants	721 participants
		25.6; (23.8 to 27.6)	25.6; (23.6 to 27.7)
Serotype 19F	Number Analyzed	732 participants	721 participants
		13.1; (12.2 to 14.1)	12.5; (11.6 to 13.5)
Serotype 23F	Number Analyzed	732 participants	721 participants
		18.1; (16.8 to 19.5)	19.2; (17.9 to 20.6)
Serotype 8	Number Analyzed	732 participants	692 participants
		9.1; (8.5 to 9.8)	1.3; (1.2 to 1.4)
Serotype 10A	Number Analyzed	732 participants	718 participants
		8.1; (7.6 to 8.7)	1.1; (1.0 to 1.1)
Serotype 11A	Number Analyzed	732 participants	719 participants
		9.8; (9.1 to 10.6)	1.1; (1.0 to 1.2)
Serotype 12F	Number Analyzed	732 participants	719 participants
		10.0; (9.4 to 10.6)	1.0; (1.0 to 1.1)
Serotype 15B	Number Analyzed	732 participants	719 participants
		8.1; (7.5 to 8.7)	1.2; (1.2 to 1.3)
Serotype 22F	Number Analyzed	732 participants	719 participants
		8.4; (7.9 to 9.1)	1.2; (1.1 to 1.3)
Serotype 33F	Number Analyzed	732 participants	719 participants
		8.8; (8.2 to 9.4)	1.1; (1.0 to 1.1)

22. Secondary Outcome

Title	Serotype-specific IgG GMFRs From 1 Month After Dose 3 to 1 Month After Dose 4
Description	GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 were reported from participants in both Dose 3 and Dose 4 evaluable immunogenicity populations.
Time Frame	from 1 month after Dose 3 to 1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 3 and Dose 4 evaluable population: participants aged 42-98 days on Dose 1, received the first 3 doses and 4 doses, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3 or Dose 4. "Number of Participants Analyzed"= maximum number of participants in both Dose 3 and Dose 4 evaluable immuno populations that had a valid IgG concentration at both timepoints. "Number Analyzed"= number of participants with valid IgG concentrations at both timepoints for the specified serotype.

Arm/Group Title		20vPnC	13vPnC
Arm/Group Description:		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed		704	687
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	704 participants	685 participants
		2.0; (1.9 to 2.1)	1.8; (1.7 to 1.9)
Serotype 3	Number Analyzed	704 participants	686 participants
		1.6; (1.5 to 1.7)	1.7; (1.6 to 1.8)
Serotype 4	Number Analyzed	703 participants	686 participants
		5.1; (4.8 to 5.5)	4.4; (4.1 to 4.8)
Serotype 5	Number Analyzed	704 participants	686 participants
		2.9; (2.7 to 3.1)	2.6; (2.4 to 2.8)
Serotype 6A	Number Analyzed	704 participants	686 participants
		4.7; (4.4 to 5.0)	4.3; (4.0 to 4.6)
Serotype 6B	Number Analyzed	700 participants	685 participants
		6.8; (6.2 to 7.4)	5.5; (5.0 to 6.0)
Serotype 7F	Number Analyzed	704 participants	686 participants
		2.3; (2.2 to 2.4)	2.2; (2.1 to 2.3)
Serotype 9V	Number Analyzed	704 participants	685 participants
		4.0; (3.7 to 4.3)	3.4; (3.2 to 3.7)
Serotype 14	Number Analyzed	703 participants	686 participants
		2.6; (2.4 to 2.9)	2.2; (2.0 to 2.5)
Serotype 18C	Number Analyzed	704 participants	686 participants
		2.7; (2.5 to 2.8)	2.6; (2.5 to 2.8)
Serotype 19A	Number Analyzed	703 participants	686 participants
		4.9; (4.6 to 5.2)	4.6; (4.2 to 4.9)
Serotype 19F	Number Analyzed	704 participants	686 participants
		3.2; (3.0 to 3.4)	2.9; (2.7 to 3.1)
Serotype 23F	Number Analyzed	704 participants	686 participants
		4.9; (4.5 to 5.3)	4.9; (4.5 to 5.3)
Serotype 8	Number Analyzed	704 participants	659 participants
		2.2; (2.0 to 2.3)	1.8; (1.6 to 2.0)
Serotype 10A	Number Analyzed	704 participants	686 participants
		5.3; (4.9 to 5.8)	1.0; (0.9 to 1.1)
Serotype 11A	Number Analyzed	704 participants	687 participants
		2.6; (2.4 to 2.8)	1.1; (1.0 to 1.3)
Serotype 12F	Number Analyzed	704 participants	687 participants
		3.3; (3.1 to 3.6)	1.0; (1.0 to 1.1)
Serotype 15B	Number Analyzed	704 participants	687 participants
		2.8; (2.6 to 3.0)	1.0; (0.9 to 1.1)
Serotype 22F	Number Analyzed	704 participants	687 participants
		2.9; (2.7 to 3.1)	1.0; (0.9 to 1.1)
Serotype 33F	Number Analyzed	704 participants	686 participants
		6.4; (5.9 to 7.0)	0.8; (0.8 to 0.9)

23. Secondary Outcome

Title	Percentage of Participants With Alternative Prespecified Hib Antibody Level 1 Month After Dose 3
Description	Antibody concentration to the Hib vaccine antigens were determined on sera collected from a randomly selected subset of participants with sufficient sera volumes. Percentage of participants with alternative prespecified Hib antibody (≥1.0 μg/mL) were reported from Dose 3 evaluable immunogenicity participants.
Time Frame	1 month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses, had at least 1 valid immunogenicity result within 27 to 56 days post Dose 3, and had no other major protocol deviations. "Number of Participant Analyzed" = Dose 3 evaluable immunogenicity population with valid Hib antibody level. "Number Analyzed" = number of participants with valid Hib antibody level.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	124	125
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	75.0; (66.4 to 82.3)	72.0; (63.3 to 79.7)

24. Secondary Outcome

Title	Geometric Mean Ratios (GMRs) of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Measles) 1 Month After Dose 4
Description	Antibody concentrations to concomitant vaccine antigen (measles) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, have at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"=number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	234	232
Geometric Mean (95% Confidence Interval); Unit of Measure: AU/mL
	277.74; (243.88 to 316.30)	215.41; (184.61 to 251.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratios
	Estimated Value	1.29
	Confidence Interval	95%; 1.05 to 1.58
	Estimation Comments	[Not Specified]

25. Secondary Outcome

Title	GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Mumps) 1 Month After Dose 4
Description	Antibody concentrations to concomitant vaccine antigen (mumps) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, have at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"=number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	234	232
Geometric Mean (95% Confidence Interval); Unit of Measure: AU/mL
	36.96; (30.82 to 44.33)	34.19; (28.94 to 40.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratios
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.38
	Estimation Comments	[Not Specified]

26. Secondary Outcome

Title	GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens (Rubella) 1 Month After Dose 4
Description	Antibody concentrations to concomitant vaccine antigen (rubella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"= number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	234	232
Geometric Mean (95% Confidence Interval); Unit of Measure: IU/mL
	49.63; (43.88 to 56.13)	40.44; (35.19 to 46.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratios
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 1.02 to 1.48
	Estimation Comments	[Not Specified]

27. Secondary Outcome

Title	GMRs of Prespecified Antibody Levels to Specific Concomitant Vaccine Antigen (Varicella) 1 Month After Dose 4
Description	Antibody concentrations to concomitant vaccine antigen (varicella) were determined on sera collected 1 month after Dose 4 from a randomly selected subset of participants with sufficient sera volumes. GMs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution and were reported from Dose 4 evaluable immunogenicity participants.
Time Frame	1 month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations as determined by the clinician. "Number of Participants Analyzed"= number of participants in Dose 4 evaluable immunogenicity population with valid antibody concentrations for the specified antigen reported at 1 month after Dose 4.

Arm/Group Title	20vPnC	13vPnC
Arm/Group Description:	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
Overall Number of Participants Analyzed	231	229
Geometric Mean (95% Confidence Interval); Unit of Measure: mIU/mL
	233.05; (207.25 to 262.06)	234.78; (208.84 to 263.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC, 13vPnC
	Comments	Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).
Method of Estimation	Estimation Parameter	Geometric Mean Ratios
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.17
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Local reactions (LR) and systemic events (SE) [systematic assessment(SA)]:within 7 days after Dose 1, 2, 3, 4; SAEs: from Dose 1 up to 6 months after Dose 4; other AEs [non-systematic assessment (non-SA)]:from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
Adverse Event Reporting Description	Same events may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study
Arm/Group Title	20vPnC		13vPnC
Arm/Group Description	Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.		Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 millilitre (mL) 13-valent Pneumococcal Conjugate Vaccine (13vPnC) intramuscularly. Dose 1 was given at enrollment and Dose 2 and 3 were given 42 to 63 days from the previous dose. Dose 4 was administered at 365 to 455 days of age.
All-Cause Mortality
	20vPnC		13vPnC
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/1001 (0.00%)		0/987 (0.00%)
Serious Adverse Events
	20vPnC		13vPnC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/1001 (4.50%)		31/987 (3.14%)
Blood and lymphatic system disorders
Anaemia * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Immune thrombocytopenia * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Microcytic anaemia * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Gastrointestinal disorders
Intussusception * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Vomiting * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
General disorders
Systemic inflammatory response syndrome * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Infections and infestations
Adenovirus infection * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Bronchiolitis * 1	4/1001 (0.40%)	6	4/987 (0.41%)	4
Bullous impetigo * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
COVID-19 * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Cellulitis * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Coronavirus infection * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Croup infectious * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Dengue fever * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Escherichia urinary tract infection * 1	0/1001 (0.00%)	0	2/987 (0.20%)	2
Gastroenteritis norovirus * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Gastroenteritis * 1	0/1001 (0.00%)	0	5/987 (0.51%)	5
Gastrointestinal viral infection * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Groin abscess * 1	1/1001 (0.10%)	2	0/987 (0.00%)	0
Hand-foot-and-mouth disease * 1	1/1001 (0.10%)	1	1/987 (0.10%)	1
Metapneumovirus bronchiolitis * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Otitis media acute * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Pneumonia necrotising * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Pneumonia respiratory syncytial viral * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Pneumonia * 1	2/1001 (0.20%)	2	1/987 (0.10%)	1
Pyelonephritis acute * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Respiratory syncytial virus bronchiolitis * 1	7/1001 (0.70%)	7	3/987 (0.30%)	3
Respiratory syncytial virus infection * 1	5/1001 (0.50%)	5	2/987 (0.20%)	2
Respiratory tract infection viral * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Urinary tract infection pseudomonal * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Urinary tract infection * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Viral infection * 1	1/1001 (0.10%)	1	1/987 (0.10%)	1
Injury, poisoning and procedural complications
Accidental exposure to product * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Accidental poisoning * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Extradural haematoma * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Fall * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Skull fracture * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Subdural haematoma * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
Thermal burn * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Metabolism and nutrition disorders
Dehydration * 1	2/1001 (0.20%)	2	1/987 (0.10%)	1
Failure to thrive * 1	2/1001 (0.20%)	2	1/987 (0.10%)	1
Nervous system disorders
Febrile convulsion * 1	2/1001 (0.20%)	2	2/987 (0.20%)	2
Hypoglycaemic seizure * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Partial seizures * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Status epilepticus * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure * 1	0/1001 (0.00%)	0	1/987 (0.10%)	1
Asthma * 1	0/1001 (0.00%)	0	1/987 (0.10%)	2
Vascular disorders
Kawasaki's disease * 1	1/1001 (0.10%)	1	0/987 (0.00%)	0
1 Term from vocabulary, MedDRA v25.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	20vPnC		13vPnC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	966/1001 (96.50%)		939/987 (95.14%)
General disorders
Injection site erythema (REDNESS) † 1	498/1001 (49.75%)	944	492/987 (49.85%)	986
Injection site pain (PAIN) † 1	689/1001 (68.83%)	1634	663/987 (67.17%)	1543
Injection site swelling (SWELLING) † 1	353/1001 (35.26%)	635	359/987 (36.37%)	707
Pyrexia (FEVER) † 1	322/1001 (32.17%)	550	314/987 (31.81%)	504
Infections and infestations
Otitis media * 1	56/1001 (5.59%)	73	50/987 (5.07%)	65
Upper respiratory tract infection * 1	114/1001 (11.39%)	137	112/987 (11.35%)	137
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE) † 1	521/1001 (52.05%)	1041	492/987 (49.85%)	1028
Nervous system disorders
Hypersomnia (INCREASED SLEEP) † 1	823/1001 (82.22%)	2309	798/987 (80.85%)	2268
Psychiatric disorders
Irritability (IRRITABILITY) † 1	894/1001 (89.31%)	3380	863/987 (87.44%)	3301
1 Term from vocabulary, MedDRA v25.0; † Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04382326
• Other Study ID Numbers: B7471011; 2019-003305-10 ( EudraCT Number )
• First Submitted: May 7, 2020
• First Posted: May 11, 2020
• Results First Submitted: August 30, 2023
• Results First Posted: December 6, 2023
• Last Update Posted: December 6, 2023