20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

• ClinicalTrials.gov Identifier: NCT04530838
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Results First Posted: April 21, 2023
• Last Update Posted: April 21, 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: 668

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 668 participants were enrolled and randomized in the study. One participant did not receive any study vaccine. One participant receive vaccination through route which was not as per randomization. Hence, data of these participants were excluded from analysis.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description	Participants received 4 doses of 0.5 milliliter (mL) 20-valent Pneumococcal Conjugate Vaccine (20vPnC) subcutaneously (SC) into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13-valent Pneumococcal Conjugate Vaccine (13vPnC) SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC intramuscularly (IM) into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Period Title: Overall Study
Started	225	224	217
Completed	217	220	211
Not Completed	8	4	6
Reason Not Completed
Other	2	1	0
Physician Decision	0	0	1
Death	0	0	1
Adverse Event	0	1	0
No longer meets eligibility criteria	1	0	2
Withdrawal by parent/guardian	5	2	2

Baseline Characteristics

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)	Total
Arm/Group Description		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Total of all reporting groups
Overall Number of Baseline Participants		225	224	217	666
Baseline 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 vaccination.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Months
	Number Analyzed	225 participants	224 participants	217 participants	666 participants
		2.4 (0.33)	2.4 (0.40)	2.4 (0.42)	2.4 (0.39)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	224 participants	217 participants	666 participants
	Female	117 52.0%	114 50.9%	106 48.8%	337 50.6%
	Male	108 48.0%	110 49.1%	111 51.2%	329 49.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	224 participants	217 participants	666 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	225 100.0%	224 100.0%	217 100.0%	666 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	225 participants	224 participants	217 participants	666 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	225 100.0%	224 100.0%	217 100.0%	666 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Description	Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
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 Dose 1.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	225	224	217
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Mild	58.2; (51.5 to 64.7)	51.3; (44.6 to 58.1)	26.3; (20.5 to 32.7)
Redness: Moderate	20.0; (15.0 to 25.8)	23.7; (18.3 to 29.8)	11.1; (7.2 to 16.0)
Redness: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Swelling: Mild	48.9; (42.2 to 55.6)	42.9; (36.3 to 49.6)	17.5; (12.7 to 23.2)
Swelling: Moderate	19.6; (14.6 to 25.3)	23.2; (17.9 to 29.3)	11.1; (7.2 to 16.0)
Swelling: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Pain at the injection site: Mild	15.6; (11.1 to 21.0)	13.4; (9.2 to 18.6)	12.4; (8.4 to 17.6)
Pain at the injection site: Moderate	1.8; (0.5 to 4.5)	2.7; (1.0 to 5.7)	3.2; (1.3 to 6.5)
Pain at the injection site: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0.5; (0.0 to 2.5)

2. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Description	Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
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 Dose 2. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	223	222	215
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Mild	52.9; (46.1 to 59.6)	53.2; (46.4 to 59.9)	24.7; (19.0 to 31.0)
Redness: Moderate	23.3; (17.9 to 29.4)	31.1; (25.1 to 37.6)	7.0; (4.0 to 11.2)
Redness: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Swelling: Mild	46.2; (39.5 to 53.0)	46.8; (40.1 to 53.6)	18.1; (13.2 to 24.0)
Swelling: Moderate	22.4; (17.1 to 28.5)	26.6; (20.9 to 32.9)	7.9; (4.7 to 12.4)
Swelling: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Pain at the injection site: Mild	13.0; (8.9 to 18.1)	16.7; (12.0 to 22.2)	9.3; (5.8 to 14.0)
Pain at the injection site: Moderate	3.6; (1.6 to 6.9)	0.5; (0.0 to 2.5)	2.3; (0.8 to 5.3)
Pain at the injection site: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)

3. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description	Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
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 Dose 3. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 3.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	222	221	215
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Mild	45.0; (38.4 to 51.8)	51.1; (44.3 to 57.9)	23.3; (17.8 to 29.5)
Redness: Moderate	33.8; (27.6 to 40.4)	34.8; (28.6 to 41.5)	8.4; (5.0 to 12.9)
Redness: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Swelling: Mild	38.7; (32.3 to 45.5)	39.8; (33.3 to 46.6)	17.7; (12.8 to 23.4)
Swelling: Moderate	30.2; (24.2 to 36.7)	35.3; (29.0 to 42.0)	9.8; (6.1 to 14.5)
Swelling: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Pain at the injection site: Mild	10.8; (7.1 to 15.7)	14.5; (10.1 to 19.8)	8.8; (5.4 to 13.5)
Pain at the injection site: Moderate	3.6; (1.6 to 7.0)	1.4; (0.3 to 3.9)	0.9; (0.1 to 3.3)
Pain at the injection site: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.7)	0.5; (0.0 to 2.6)

4. Primary Outcome

Title	Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Description	Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
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 Dose 4. Here, "Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	218	220	212
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Redness: Mild	37.2; (30.7 to 43.9)	36.4; (30.0 to 43.1)	20.8; (15.5 to 26.8)
Redness: Moderate	49.1; (42.3 to 55.9)	49.1; (42.3 to 55.9)	11.8; (7.8 to 16.9)
Redness: Severe	0.5; (0.0 to 2.5)	0.5; (0.0 to 2.5)	0; (0.0 to 1.7)
Swelling: Mild	37.6; (31.2 to 44.4)	35.9; (29.6 to 42.6)	13.2; (9.0 to 18.5)
Swelling: Moderate	42.2; (35.6 to 49.1)	41.8; (35.2 to 48.6)	10.8; (7.0 to 15.8)
Swelling: Severe	0.5; (0.0 to 2.5)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Pain at the injection site: Mild	19.7; (14.7 to 25.6)	19.1; (14.1 to 24.9)	10.4; (6.6 to 15.3)
Pain at the injection site: Moderate	1.4; (0.3 to 4.0)	3.2; (1.3 to 6.4)	3.3; (1.3 to 6.7)
Pain at the injection site: Severe	0; (0.0 to 1.7)	0; (0.0 to 1.7)	0; (0.0 to 1.7)

5. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description	Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
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 Dose 1.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	225	224	217
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=37.5 degree C	9.8; (6.2 to 14.4)	12.9; (8.8 to 18.1)	9.7; (6.1 to 14.4)
Fever: >=37.5°C to 38.4 degree C	9.3; (5.9 to 13.9)	12.5; (8.5 to 17.6)	9.7; (6.1 to 14.4)
Fever: >38.4°C to 38.9 degree C	0.4; (0.0 to 2.5)	0.4; (0.0 to 2.5)	0; (0.0 to 1.7)
Fever: >38.9 to 40.0 degree C	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Fever: >40.0 degree C	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Decreased appetite: Mild	3.6; (1.5 to 6.9)	7.1; (4.1 to 11.3)	3.2; (1.3 to 6.5)
Decreased appetite: Moderate	1.8; (0.5 to 4.5)	3.1; (1.3 to 6.3)	3.2; (1.3 to 6.5)
Decreased appetite: Severe	0; (0.0 to 1.6)	0.4; (0.0 to 2.5)	0; (0.0 to 1.7)
Drowsiness: Mild	40.4; (34.0 to 47.2)	42.0; (35.4 to 48.7)	42.9; (36.2 to 49.7)
Drowsiness: Moderate	0.9; (0.1 to 3.2)	2.2; (0.7 to 5.1)	4.1; (1.9 to 7.7)
Drowsiness: Severe	0; (0.0 to 1.6)	0.4; (0.0 to 2.5)	0; (0.0 to 1.7)
Irritability: Mild	13.8; (9.6 to 19.0)	11.2; (7.4 to 16.0)	12.9; (8.7 to 18.1)
Irritability: Moderate	12.0; (8.1 to 17.0)	13.4; (9.2 to 18.6)	11.5; (7.6 to 16.5)
Irritability: Severe	1.3; (0.3 to 3.8)	1.8; (0.5 to 4.5)	0.5; (0.0 to 2.5)

6. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Description	Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
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 Dose 2. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 2.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	223	222	215
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=37.5 degree C	20.2; (15.1 to 26.1)	21.2; (16.0 to 27.1)	18.1; (13.2 to 24.0)
Fever: >=37.5 to 38.4 degree C	15.2; (10.8 to 20.6)	17.6; (12.8 to 23.2)	14.9; (10.4 to 20.4)
Fever: >38.4 to 38.9 degree C	3.1; (1.3 to 6.4)	2.3; (0.7 to 5.2)	1.9; (0.5 to 4.7)
Fever: >38.9 to 40.0 degree C	1.8; (0.5 to 4.5)	1.4; (0.3 to 3.9)	1.4; (0.3 to 4.0)
Fever: >40.0 degree C	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Decreased appetite: Mild	4.5; (2.2 to 8.1)	6.8; (3.8 to 10.9)	5.1; (2.6 to 9.0)
Decreased appetite: Moderate	5.8; (3.1 to 9.8)	5.0; (2.5 to 8.7)	4.7; (2.3 to 8.4)
Decreased appetite: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Drowsiness: Mild	39.9; (33.4 to 46.7)	48.6; (41.9 to 55.4)	39.5; (33.0 to 46.4)
Drowsiness: Moderate	3.1; (1.3 to 6.4)	4.1; (1.9 to 7.6)	2.3; (0.8 to 5.3)
Drowsiness: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.6)	0; (0.0 to 1.7)
Irritability: Mild	12.6; (8.5 to 17.6)	16.7; (12.0 to 22.2)	10.2; (6.5 to 15.1)
Irritability: Moderate	12.1; (8.1 to 17.1)	14.9; (10.5 to 20.2)	15.3; (10.8 to 20.9)
Irritability: Severe	1.3; (0.3 to 3.9)	0.5; (0.0 to 2.5)	1.4; (0.3 to 4.0)

7. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Description	Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
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 Dose 3. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 3

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	222	221	215
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=37.5 degree C	15.3; (10.8 to 20.7)	19.9; (14.9 to 25.8)	15.3; (10.8 to 20.9)
Fever: >=37.5 to 38.4 degree C	13.5; (9.3 to 18.7)	16.3; (11.7 to 21.8)	12.6; (8.4 to 17.7)
Fever: >38.4 to 38.9 degree C	1.4; (0.3 to 3.9)	2.7; (1.0 to 5.8)	1.9; (0.5 to 4.7)
Fever: >38.9 to 40.0 degree C	0.5; (0.0 to 2.5)	0.9; (0.1 to 3.2)	0.9; (0.1 to 3.3)
Fever: >40.0 degree C	0; (0.0 to 1.6)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Decreased appetite: Mild	5.0; (2.5 to 8.7)	7.2; (4.2 to 11.5)	4.2; (1.9 to 7.8)
Decreased appetite: Moderate	2.7; (1.0 to 5.8)	3.6; (1.6 to 7.0)	3.7; (1.6 to 7.2)
Decreased appetite: Severe	0.5; (0.0 to 2.5)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Drowsiness: Mild	24.8; (19.2 to 31.0)	32.6; (26.4 to 39.2)	32.6; (26.3 to 39.3)
Drowsiness: Moderate	1.4; (0.3 to 3.9)	1.8; (0.5 to 4.6)	1.4; (0.3 to 4.0)
Drowsiness: Severe	0; (0.0 to 1.6)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Irritability: Mild	16.7; (12.0 to 22.2)	10.9; (7.1 to 15.7)	14.0; (9.6 to 19.3)
Irritability: Moderate	8.6; (5.2 to 13.0)	9.0; (5.6 to 13.6)	13.0; (8.8 to 18.3)
Irritability: Severe	0.5; (0.0 to 2.5)	0; (0.0 to 1.7)	0.9; (0.1 to 3.3)

8. Primary Outcome

Title	Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Description	Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
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 Dose 4. Here, "Overall Number of Participants Analyzed" = number of participants with any e-diary data reported after Dose 4.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	218	220	212
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Fever: >=37.5 degree C	42.7; (36.0 to 49.5)	39.5; (33.0 to 46.3)	38.2; (31.6 to 45.1)
Fever: >=37.5 to 38.4 degree C	25.7; (20.0 to 32.0)	29.1; (23.2 to 35.6)	24.1; (18.5 to 30.4)
Fever: >38.4 to 38.9 degree C	10.1; (6.4 to 14.9)	5.9; (3.2 to 9.9)	6.1; (3.3 to 10.3)
Fever: >38.9 to 40.0 degree C	6.4; (3.6 to 10.5)	4.5; (2.2 to 8.2)	8.0; (4.7 to 12.5)
Fever: >40.0 degree C	0.5; (0.0 to 2.5)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Decreased appetite: Mild	6.4; (3.6 to 10.5)	6.8; (3.9 to 11.0)	6.1; (3.3 to 10.3)
Decreased appetite: Moderate	7.3; (4.3 to 11.6)	7.7; (4.6 to 12.1)	5.7; (3.0 to 9.7)
Decreased appetite: Severe	0; (0.0 to 1.7)	0; (0.0 to 1.7)	0.9; (0.1 to 3.4)
Drowsiness: Mild	24.3; (18.8 to 30.6)	23.6; (18.2 to 29.8)	29.7; (23.7 to 36.4)
Drowsiness: Moderate	1.4; (0.3 to 4.0)	2.3; (0.7 to 5.2)	1.9; (0.5 to 4.8)
Drowsiness: Severe	0; (0.0 to 1.7)	0; (0.0 to 1.7)	0; (0.0 to 1.7)
Irritability: Mild	14.2; (9.9 to 19.6)	15.5; (10.9 to 20.9)	15.1; (10.6 to 20.6)
Irritability: Moderate	7.3; (4.3 to 11.6)	11.4; (7.5 to 16.3)	9.4; (5.9 to 14.2)
Irritability: Severe	0.9; (0.1 to 3.3)	0.9; (0.1 to 3.2)	0.5; (0.0 to 2.6)

9. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Description	An adverse event (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.
Time Frame	Day 1 of 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 and had safety data after any dose.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	225	224	217
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	47.6; (40.9 to 54.3)	55.4; (48.6 to 62.0)	58.5; (51.7 to 65.2)

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.
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.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	218	220	212
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	40.4; (33.8 to 47.2)	43.2; (36.5 to 50.0)	43.9; (37.1 to 50.8)

11. Primary Outcome

Title	Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4
Description	A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Time Frame	From Dose 1 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.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	225	224	217
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	6.2; (3.4 to 10.2)	4.0; (1.9 to 7.5)	7.4; (4.3 to 11.7)

12. Primary Outcome

Title	Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4
Description	An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Time Frame	From Dose 1 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, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.

Arm/Group Title	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed	225	224	217
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	10.7; (7.0 to 15.5)	8.9; (5.5 to 13.5)	8.3; (5.0 to 12.8)

13. Primary Outcome

Title	Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Description	Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Time Frame	1 Month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, had no other major protocol deviations per clinician.Here, "N" = participants with an IgG concentration greater than or equal to(>=)predefined level for given serotype,"n" =participants with valid assay results for specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		221	220	213
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Serotype: 1	Number Analyzed	221 participants	220 participants	213 participants
		97.7; (94.8 to 99.3)	99.1; (96.8 to 99.9)	92.0; (87.5 to 95.3)
Serotype: 3	Number Analyzed	221 participants	220 participants	213 participants
		96.4; (93.0 to 98.4)	99.1; (96.8 to 99.9)	95.3; (91.5 to 97.7)
Serotype: 4	Number Analyzed	221 participants	220 participants	213 participants
		96.8; (93.6 to 98.7)	99.1; (96.8 to 99.9)	94.8; (90.9 to 97.4)
Serotype: 5	Number Analyzed	221 participants	220 participants	213 participants
		92.3; (88.0 to 95.5)	97.3; (94.2 to 99.0)	93.0; (88.7 to 96.0)
Serotype: 6A	Number Analyzed	221 participants	220 participants	213 participants
		90.0; (85.3 to 93.7)	98.2; (95.4 to 99.5)	94.8; (90.9 to 97.4)
Serotype: 6B	Number Analyzed	221 participants	220 participants	213 participants
		87.8; (82.7 to 91.8)	96.4; (93.0 to 98.4)	82.2; (76.3 to 87.1)
Serotype: 7F	Number Analyzed	221 participants	220 participants	213 participants
		95.9; (92.4 to 98.1)	99.1; (96.8 to 99.9)	94.8; (90.9 to 97.4)
Serotype: 9V	Number Analyzed	221 participants	220 participants	213 participants
		95.9; (92.4 to 98.1)	98.6; (96.1 to 99.7)	93.0; (88.7 to 96.0)
Serotype: 14	Number Analyzed	220 participants	220 participants	213 participants
		96.8; (93.6 to 98.7)	97.7; (94.8 to 99.3)	96.2; (92.7 to 98.4)
Serotype: 18C	Number Analyzed	221 participants	220 participants	213 participants
		96.8; (93.6 to 98.7)	99.1; (96.8 to 99.9)	94.8; (90.9 to 97.4)
Serotype: 19A	Number Analyzed	221 participants	220 participants	213 participants
		99.5; (97.5 to 100.0)	99.5; (97.5 to 100.0)	99.1; (96.6 to 99.9)
Serotype: 19F	Number Analyzed	221 participants	220 participants	213 participants
		100.0; (98.3 to 100.0)	100.0; (98.3 to 100.0)	100.0; (98.3 to 100.0)
Serotype: 23F	Number Analyzed	221 participants	220 participants	213 participants
		89.6; (84.8 to 93.3)	93.6; (89.6 to 96.5)	88.7; (83.7 to 92.6)
Serotype: 8	Number Analyzed	221 participants	219 participants	213 participants
		99.5; (97.5 to 100.0)	0.9; (0.1 to 3.3)	99.5; (97.4 to 100.0)
Serotype: 10A	Number Analyzed	221 participants	220 participants	213 participants
		60.2; (53.4 to 66.7)	1.8; (0.5 to 4.6)	59.6; (52.7 to 66.3)
Serotype: 11A	Number Analyzed	221 participants	220 participants	213 participants
		100.0; (98.3 to 100.0)	2.7; (1.0 to 5.8)	100.0; (98.3 to 100.0)
Serotype: 12F	Number Analyzed	221 participants	220 participants	213 participants
		74.7; (68.4 to 80.3)	0.9; (0.1 to 3.2)	74.6; (68.3 to 80.3)
Serotype: 15B	Number Analyzed	221 participants	220 participants	213 participants
		99.1; (96.8 to 99.9)	8.2; (4.9 to 12.6)	98.6; (95.9 to 99.7)
Serotype: 22F	Number Analyzed	221 participants	220 participants	213 participants
		100.0; (98.3 to 100.0)	0.9; (0.1 to 3.2)	100.0; (98.3 to 100.0)
Serotype: 33F	Number Analyzed	219 participants	220 participants	212 participants
		95.0; (91.2 to 97.5)	3.2; (1.3 to 6.4)	92.5; (88.0 to 95.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 1: 2-Sided 95% 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	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -4.4 to 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.7
	Confidence Interval	(2-Sided) 95%; -6.2 to 0.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.3
	Confidence Interval	(2-Sided) 95%; -5.6 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -9.6 to -0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-8.1
	Confidence Interval	(2-Sided) 95%; -13.0 to -4.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-8.6
	Confidence Interval	(2-Sided) 95%; -14.0 to -3.7
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-3.2
	Confidence Interval	(2-Sided) 95%; -6.8 to -0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.7
	Confidence Interval	(2-Sided) 95%; -6.4 to 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -4.4 to 2.4
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.3
	Confidence Interval	(2-Sided) 95%; -5.6 to 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.1 to 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.7 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -9.5 to 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 8: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; 3.0 to 10.0
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 10A: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-33.5
	Confidence Interval	(2-Sided) 95%; -40.7 to -26.2
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 11A: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	6.4
	Confidence Interval	(2-Sided) 95%; 3.8 to 10.4
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 12F: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-19.0
	Confidence Interval	(2-Sided) 95%; -25.7 to -12.5
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 15B: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	5.5
	Confidence Interval	(2-Sided) 95%; 2.2 to 9.6
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 22F: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	6.4
	Confidence Interval	(2-Sided) 95%; 3.8 to 10.4
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 33F: 2-Sided 95% CI 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 are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -3.2 to 6.0
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -10.4 to -1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -5.2 to 2.9
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.2 to 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -4.5 to 5.8
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	4.8
	Confidence Interval	(2-Sided) 95%; -0.2 to 10.0
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-5.6
	Confidence Interval	(2-Sided) 95%; -12.5 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -5.4 to 3.1
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -7.7 to 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -4.4 to 3.2
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -6.2 to 1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -3.0 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.8 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -6.9 to 5.1
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -2.2 to 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -9.8 to 8.6
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.8 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -8.2 to 8.2
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -3.3 to 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -1.8 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -7.5 to 2.2
	Estimation Comments	[Not Specified]

14. Secondary Outcome

Title	Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3
Description	Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame	1 Month after Dose 3

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at first vaccination, received first 3 doses as randomized, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, "N" = participants with an IgG concentration >= predefined level for given serotype and "n" =participants with valid assay results for specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		221	220	213
Geometric Mean (95% Confidence Interval); Unit of Measure: Micrograms per milliliter
Serotype 1	Number Analyzed	221 participants	220 participants	213 participants
		1.37; (1.25 to 1.51)	2.21; (1.98 to 2.47)	1.17; (1.04 to 1.31)
Serotype 3	Number Analyzed	221 participants	220 participants	213 participants
		1.29; (1.18 to 1.41)	1.81; (1.66 to 1.98)	1.10; (0.99 to 1.22)
Serotype 4	Number Analyzed	221 participants	220 participants	213 participants
		1.76; (1.57 to 1.97)	2.96; (2.64 to 3.32)	1.73; (1.52 to 1.97)
Serotype 5	Number Analyzed	221 participants	220 participants	213 participants
		1.01; (0.89 to 1.16)	1.72; (1.51 to 1.96)	1.00; (0.87 to 1.14)
Serotype 6A	Number Analyzed	221 participants	220 participants	213 participants
		1.38; (1.21 to 1.57)	2.34; (2.09 to 2.62)	1.64; (1.42 to 1.88)
Serotype 6B	Number Analyzed	221 participants	220 participants	213 participants
		0.42; (0.35 to 0.50)	0.83; (0.71 to 0.97)	0.39; (0.32 to 0.48)
Serotype 7F	Number Analyzed	221 participants	220 participants	213 participants
		1.58; (1.43 to 1.75)	2.19; (1.95 to 2.46)	1.52; (1.35 to 1.71)
Serotype 9V	Number Analyzed	221 participants	220 participants	213 participants
		1.46; (1.32 to 1.61)	2.11; (1.88 to 2.36)	1.45; (1.29 to 1.64)
Serotype 14	Number Analyzed	220 participants	220 participants	213 participants
		2.79; (2.45 to 3.18)	3.31; (2.90 to 3.78)	2.43; (2.13 to 2.76)
Serotype 18C	Number Analyzed	221 participants	220 participants	213 participants
		1.67; (1.51 to 1.86)	2.52; (2.26 to 2.82)	1.54; (1.38 to 1.72)
Serotype 19A	Number Analyzed	221 participants	220 participants	213 participants
		2.41; (2.19 to 2.65)	3.19; (2.86 to 3.56)	2.36; (2.11 to 2.64)
Serotype 19F	Number Analyzed	221 participants	220 participants	213 participants
		2.81; (2.60 to 3.04)	3.73; (3.41 to 4.08)	2.76; (2.53 to 3.02)
Serotype 23F	Number Analyzed	221 participants	220 participants	213 participants
		1.32; (1.15 to 1.51)	2.05; (1.79 to 2.34)	1.29; (1.13 to 1.48)
Serotype 8	Number Analyzed	221 participants	219 participants	213 participants
		3.32; (3.05 to 3.61)	0.01; (0.01 to 0.01)	3.29; (2.97 to 3.64)
Serotype 10A	Number Analyzed	221 participants	220 participants	213 participants
		0.50; (0.42 to 0.60)	0.01; (0.01 to 0.02)	0.47; (0.39 to 0.56)
Serotype 11A	Number Analyzed	221 participants	220 participants	213 participants
		5.63; (5.17 to 6.14)	0.02; (0.02 to 0.02)	5.22; (4.73 to 5.77)
Serotype 12F	Number Analyzed	221 participants	220 participants	213 participants
		0.79; (0.67 to 0.93)	0.01; (0.01 to 0.01)	0.72; (0.60 to 0.85)
Serotype 15B	Number Analyzed	221 participants	220 participants	213 participants
		6.77; (6.04 to 7.60)	0.04; (0.03 to 0.05)	6.80; (6.03 to 7.67)
Serotype 22F	Number Analyzed	221 participants	220 participants	213 participants
		4.94; (4.54 to 5.38)	0.01; (0.00 to 0.01)	4.41; (3.99 to 4.88)
Serotype 33F	Number Analyzed	219 participants	220 participants	212 participants
		1.70; (1.51 to 1.92)	0.02; (0.02 to 0.03)	1.62; (1.40 to 1.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.72
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.63 to 0.81
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.51 to 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.71
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.59
	Confidence Interval	(2-Sided) 95%; 0.50 to 0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.40 to 0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.84
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.80
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.84
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.01
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.57 to 0.77
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.65 to 0.87
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.75
	Confidence Interval	(2-Sided) 95%; 0.67 to 0.85
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.53 to 0.78
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	4.01
	Confidence Interval	(2-Sided) 95%; 3.36 to 4.79
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.48 to 0.76
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	6.80
	Confidence Interval	(2-Sided) 95%; 5.69 to 8.13
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.20
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	8.18
	Confidence Interval	(2-Sided) 95%; 6.75 to 9.92
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	5.97
	Confidence Interval	(2-Sided) 95%; 5.00 to 7.12
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 13vPnC (SC)
	Comments	Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Non-Inferiority
	Comments	For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	2.06
	Confidence Interval	(2-Sided) 95%; 1.69 to 2.51
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.73 to 0.99
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.74 to 0.98
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.16
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.19
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.98 to 1.44
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.21
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.12
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.16
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.04
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.07
	Estimation Comments	[Not Specified]

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.13
	Estimation Comments	[Not Specified]

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.10
	Estimation Comments	[Not Specified]

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.19
	Estimation Comments	[Not Specified]

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.13
	Estimation Comments	[Not Specified]

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.20
	Estimation Comments	[Not Specified]

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.06
	Estimation Comments	[Not Specified]

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.15
	Estimation Comments	[Not Specified]

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.18
	Estimation Comments	[Not Specified]

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.02
	Estimation Comments	[Not Specified]

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	20vPnC (SC), 20vPnC (IM)
	Comments	Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	GMR
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.15
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4
Description	Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Time Frame	1 Month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population included eligible participants who were 2 to 6 months of age at Dose 1 and 12 to 15 months of age at Dose 4, received all 4 doses as randomized, had at least 1 valid assay result from the blood collection within 27 to 56 days after Dose 4, and had no other major protocol deviations per clinician. Here,"N" = participants with an IgG concentration >= predefined level for given serotype and "n"=participants with valid assay results for specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		217	220	211
Geometric Mean (95% Confidence Interval); Unit of Measure: Micrograms per milliliter
Serotype 1	Number Analyzed	217 participants	220 participants	211 participants
		2.79; (2.50 to 3.12)	4.62; (4.11 to 5.19)	2.78; (2.47 to 3.12)
Serotype 3	Number Analyzed	217 participants	220 participants	211 participants
		0.97; (0.87 to 1.08)	1.44; (1.30 to 1.59)	1.08; (0.96 to 1.21)
Serotype 4	Number Analyzed	217 participants	220 participants	211 participants
		6.93; (6.14 to 7.83)	10.01; (8.89 to 11.27)	7.31; (6.51 to 8.20)
Serotype 5	Number Analyzed	217 participants	220 participants	211 participants
		2.96; (2.63 to 3.34)	4.64; (4.13 to 5.21)	2.94; (2.59 to 3.33)
Serotype 6A	Number Analyzed	217 participants	220 participants	211 participants
		11.90; (10.61 to 13.34)	17.25; (15.66 to 18.99)	13.92; (12.43 to 15.59)
Serotype 6B	Number Analyzed	216 participants	220 participants	211 participants
		7.18; (6.30 to 8.18)	10.48; (9.46 to 11.61)	7.50; (6.58 to 8.55)
Serotype 7F	Number Analyzed	217 participants	220 participants	211 participants
		4.46; (4.04 to 4.92)	6.62; (5.95 to 7.38)	4.85; (4.34 to 5.42)
Serotype 9V	Number Analyzed	217 participants	220 participants	211 participants
		4.54; (4.04 to 5.09)	6.62; (5.93 to 7.39)	5.38; (4.81 to 6.02)
Serotype 14	Number Analyzed	217 participants	220 participants	211 participants
		8.23; (7.27 to 9.31)	10.30; (9.25 to 11.47)	9.19; (8.10 to 10.43)
Serotype 18C	Number Analyzed	217 participants	220 participants	211 participants
		3.95; (3.50 to 4.45)	5.97; (5.27 to 6.75)	3.81; (3.38 to 4.30)
Serotype 19A	Number Analyzed	217 participants	219 participants	211 participants
		7.62; (6.82 to 8.52)	8.97; (8.08 to 9.95)	7.92; (7.06 to 8.89)
Serotype 19F	Number Analyzed	217 participants	220 participants	211 participants
		8.74; (7.84 to 9.73)	11.02; (9.96 to 12.20)	8.56; (7.66 to 9.56)
Serotype 23F	Number Analyzed	217 participants	220 participants	211 participants
		7.01; (6.16 to 7.97)	11.76; (10.42 to 13.28)	7.39; (6.49 to 8.42)
Serotype 8	Number Analyzed	217 participants	219 participants	211 participants
		5.84; (5.23 to 6.53)	0.02; (0.02 to 0.03)	5.88; (5.23 to 6.62)
Serotype 10A	Number Analyzed	217 participants	220 participants	211 participants
		6.98; (6.13 to 7.93)	0.01; (0.01 to 0.01)	8.02; (7.02 to 9.16)
Serotype 11A	Number Analyzed	217 participants	220 participants	211 participants
		5.73; (5.08 to 6.46)	0.02; (0.01 to 0.02)	5.78; (5.14 to 6.50)
Serotype 12F	Number Analyzed	217 participants	220 participants	211 participants
		2.73; (2.41 to 3.09)	0.01; (0.01 to 0.01)	2.69; (2.36 to 3.06)
Serotype 15B	Number Analyzed	217 participants	220 participants	211 participants
		18.45; (16.73 to 20.36)	0.03; (0.03 to 0.04)	21.83; (19.53 to 24.41)
Serotype 22F	Number Analyzed	217 participants	220 participants	211 participants
		14.07; (12.67 to 15.63)	0.00; (0.00 to 0.01)	14.21; (12.61 to 16.00)
Serotype 33F	Number Analyzed	217 participants	220 participants	211 participants
		10.29; (9.28 to 11.40)	0.02; (0.01 to 0.02)	11.13; (9.99 to 12.39)

16. Secondary Outcome

Title	Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4
Description	20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.
Time Frame	1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4

Outcome Measure Data

Analysis Population Description

For 1 month after Dose 3 and before Dose 4: Dose 3 evaluable immunogenicity population set were analyzed and for 1 month after Dose 4: Dose 4 evaluable immunogenicity population for 1 month after Dose 4 OPA GMTs were analyzed. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid results for the specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		73	75	72
Geometric Mean (95% Confidence Interval); Unit of Measure: Titers
Serotype 1:1 Month after Dose 3	Number Analyzed	71 participants	70 participants	72 participants
		55; (43 to 71)	126; (104 to 152)	56; (45 to 70)
Serotype 1:Before Dose. 4	Number Analyzed	71 participants	71 participants	71 participants
		11; (10 to 12)	13; (11 to 16)	10; (9 to 11)
Serotype 1:1 Month after Dose 4	Number Analyzed	70 participants	72 participants	68 participants
		162; (125 to 210)	386; (306 to 486)	194; (150 to 251)
Serotype 3:1 Month after Dose 3	Number Analyzed	71 participants	70 participants	72 participants
		107; (86 to 134)	170; (147 to 196)	120; (103 to 139)
Serotype 3:Before Dose 4	Number Analyzed	70 participants	70 participants	69 participants
		16; (13 to 20)	20; (16 to 25)	16; (12 to 20)
Serotype 3: 1 Month after Dose 4	Number Analyzed	68 participants	70 participants	66 participants
		131; (114 to 150)	193; (165 to 226)	150; (126 to 179)
Serotype 4:1 Month after Dose 3	Number Analyzed	71 participants	72 participants	65 participants
		1864; (1565 to 2219)	1768; (1393 to 2245)	1617; (1298 to 2015)
Serotype 4: Before Dose 4	Number Analyzed	68 participants	67 participants	70 participants
		25; (18 to 37)	44; (29 to 66)	21; (15 to 28)
Serotype 4:1 Month after Dose 4	Number Analyzed	70 participants	71 participants	67 participants
		1627; (1232 to 2148)	2038; (1471 to 2825)	1544; (1224 to 1948)
Serotype 5:1 Month after Dose 3	Number Analyzed	71 participants	70 participants	72 participants
		95; (79 to 114)	154; (131 to 183)	91; (77 to 109)
Serotype 5:Before Dose 4	Number Analyzed	71 participants	71 participants	71 participants
		16; (15 to 17)	18; (16 to 19)	15; (14 to 16)
Serotype 5:1 Month after Dose 4	Number Analyzed	70 participants	72 participants	68 participants
		172; (140 to 212)	248; (204 to 303)	141; (112 to 179)
Serotype 6A:1 Month after Dose 3	Number Analyzed	71 participants	70 participants	72 participants
		2709; (2283 to 3213)	3339; (2777 to 4013)	3120; (2562 to 3799)
Serotype 6A:Before Dose 4	Number Analyzed	67 participants	70 participants	66 participants
		83; (56 to 122)	173; (116 to 258)	95; (62 to 147)
Serotype 6A:1 Month after Dose 4	Number Analyzed	70 participants	71 participants	68 participants
		3249; (2686 to 3928)	5455; (4379 to 6795)	3489; (2831 to 4300)
Serotype 6B:1 Month after Dose 3	Number Analyzed	70 participants	69 participants	72 participants
		1548; (1247 to 1921)	2489; (2005 to 3088)	1563; (1215 to 2010)
Serotype 6B:Before Dose 4	Number Analyzed	68 participants	65 participants	70 participants
		40; (29 to 54)	75; (49 to 115)	44; (31 to 63)
Serotype 6B:1 Month after Dose 4	Number Analyzed	70 participants	70 participants	66 participants
		2304; (1811 to 2933)	4319; (3478 to 5362)	2552; (2006 to 3247)
Serotype 7F:1 Month after Dose 3	Number Analyzed	69 participants	74 participants	69 participants
		4160; (3406 to 5081)	4428; (3821 to 5131)	4491; (3675 to 5490)
Serotype 7F:Before Dose 4	Number Analyzed	65 participants	70 participants	69 participants
		626; (436 to 899)	761; (579 to 1000)	689; (487 to 975)
Serotype 7F:1 Month after Dose 4	Number Analyzed	70 participants	71 participants	67 participants
		4735; (3824 to 5863)	6361; (5024 to 8054)	4703; (3704 to 5972)
Serotype 9V:1 Month after Dose 3	Number Analyzed	72 participants	74 participants	67 participants
		1807; (1432 to 2279)	2388; (1986 to 2870)	1929; (1554 to 2394)
Serotype 9V:Before Dose 4	Number Analyzed	65 participants	70 participants	67 participants
		183; (134 to 251)	204; (151 to 274)	212; (149 to 302)
Serotype 9V:1 Month after Dose 4	Number Analyzed	70 participants	70 participants	68 participants
		4199; (3322 to 5309)	5162; (4349 to 6127)	4201; (3418 to 5164)
Serotype 14:1 Month after Dose 3	Number Analyzed	70 participants	69 participants	72 participants
		1922; (1429 to 2585)	2593; (1999 to 3362)	2103; (1527 to 2897)
Serotype 14:Before Dose 4	Number Analyzed	68 participants	71 participants	68 participants
		426; (307 to 592)	469; (346 to 634)	357; (251 to 509)
Serotype 14:1 Month after Dose 4	Number Analyzed	71 participants	70 participants	68 participants
		1673; (1331 to 2102)	1706; (1385 to 2102)	2005; (1631 to 2463)
Serotype 18C:1 Month after Dose 3	Number Analyzed	71 participants	74 participants	70 participants
		5124; (4381 to 5992)	5355; (4617 to 6212)	4908; (4037 to 5967)
Serotype 18C:Before Dose 4	Number Analyzed	65 participants	69 participants	68 participants
		122; (76 to 198)	173; (112 to 267)	89; (56 to 143)
Serotype 18C:1 Month after Dose 4	Number Analyzed	70 participants	70 participants	66 participants
		4477; (3528 to 5681)	6315; (5081 to 7848)	4249; (3355 to 5381)
Serotype 19A:1 Month after Dose 3	Number Analyzed	72 participants	73 participants	67 participants
		638; (535 to 762)	676; (551 to 830)	553; (441 to 693)
Serotype 19A:Before Dose 4	Number Analyzed	67 participants	71 participants	67 participants
		13; (10 to 18)	20; (14 to 28)	12; (10 to 16)
Serotype 19A:1 Month after Dose 4	Number Analyzed	71 participants	72 participants	68 participants
		1860; (1530 to 2261)	2534; (2044 to 3143)	1722; (1379 to 2151)
Serotype 19F:1 Month after Dose 3	Number Analyzed	71 participants	70 participants	71 participants
		449; (356 to 566)	624; (494 to 788)	488; (411 to 580)
Serotype 19F:Before Dose 4	Number Analyzed	70 participants	70 participants	70 participants
		26; (24 to 29)	25; (24 to 26)	26; (23 to 29)
Serotype 19F:1 Month after Dose 4	Number Analyzed	71 participants	71 participants	68 participants
		1071; (846 to 1356)	1783; (1364 to 2331)	962; (753 to 1230)
Serotype 23F:1 Month after Dose 3	Number Analyzed	72 participants	74 participants	71 participants
		1580; (1211 to 2061)	1849; (1499 to 2281)	1402; (1103 to 1782)
Serotype 23F:Before Dose 4	Number Analyzed	64 participants	70 participants	66 participants
		42; (24 to 73)	62; (36 to 107)	24; (15 to 39)
Serotype 23F:1 Month after Dose 4	Number Analyzed	71 participants	70 participants	68 participants
		2609; (2015 to 3377)	3772; (2966 to 4796)	2052; (1668 to 2523)
Serotype 8:1 Month after Dose 3	Number Analyzed	70 participants	72 participants	66 participants
		1532; (1215 to 1933)	16; (15 to 18)	1541; (1220 to 1946)
Serotype 8:Before Dose 4	Number Analyzed	65 participants	73 participants	65 participants
		166; (119 to 230)	20; (17 to 24)	147; (105 to 205)
Serotype 8:1 Month after Dose 4	Number Analyzed	64 participants	71 participants	64 participants
		2970; (2412 to 3658)	27; (20 to 36)	3208; (2525 to 4077)
Serotype 10A:1 Month after Dose 3	Number Analyzed	63 participants	75 participants	63 participants
		6977; (5204 to 9354)	40; (33 to 47)	6780; (5436 to 8456)
Serotype 10A:Before Dose 4	Number Analyzed	61 participants	70 participants	62 participants
		1985; (1422 to 2772)	78; (51 to 118)	2066; (1439 to 2967)
Serotype 10A:1 Month after Dose 4	Number Analyzed	61 participants	68 participants	58 participants
		9030; (6855 to 11893)	87; (56 to 136)	8269; (6252 to 10937)
Serotype 11A:1 Month after Dose 3	Number Analyzed	73 participants	73 participants	67 participants
		1894; (1540 to 2330)	58; (47 to 71)	1838; (1451 to 2327)
Serotype 11A:Before Dose 4	Number Analyzed	70 participants	70 participants	64 participants
		416; (258 to 670)	95; (64 to 142)	247; (150 to 405)
Serotype 11A: 1 Month after Dose 4	Number Analyzed	70 participants	69 participants	65 participants
		3958; (2973 to 5269)	90; (62 to 132)	4200; (3187 to 5534)
Serotype 12F:1 Month after Dose 3	Number Analyzed	46 participants	75 participants	44 participants
		35278; (23575 to 52790)	24; (24 to 25)	21475; (14378 to 32074)
Serotype 12F:Before Dose 4	Number Analyzed	58 participants	69 participants	64 participants
		3984; (3017 to 5261)	35; (26 to 47)	4904; (3909 to 6153)
Serotype 12F:1 Month after Dose 4	Number Analyzed	57 participants	74 participants	47 participants
		15611; (11336 to 21499)	43; (31 to 60)	18899; (14215 to 25125)
Serotype 15B:1 Month after Dose 3	Number Analyzed	71 participants	74 participants	66 participants
		6981; (5726 to 8511)	17; (15 to 20)	5707; (4129 to 7889)
Serotype 15B:Before Dose 4	Number Analyzed	64 participants	73 participants	65 participants
		578; (345 to 969)	26; (18 to 39)	609; (331 to 1121)
Serotype 15B:1 Month after Dose 4	Number Analyzed	65 participants	71 participants	61 participants
		7280; (5594 to 9475)	32; (20 to 50)	7770; (6448 to 9363)
Serotype 22F:1 Month after Dose 3	Number Analyzed	62 participants	75 participants	61 participants
		21864; (16413 to 29125)	10; (8 to 11)	19276; (14969 to 24822)
Serotype 22F:Before Dose 4	Number Analyzed	66 participants	72 participants	64 participants
		2562; (1869 to 3512)	16; (11 to 24)	2014; (1477 to 2745)
Serotype 22F:1 Month after Dose 4	Number Analyzed	58 participants	74 participants	52 participants
		28435; (19414 to 41649)	18; (12 to 27)	23480; (17229 to 31998)
Serotype 33F:1 Month after Dose 3	Number Analyzed	57 participants	71 participants	59 participants
		20162; (13581 to 29930)	177; (160 to 195)	15931; (11550 to 21974)
Serotype 33F:Before Dose 4	Number Analyzed	56 participants	72 participants	60 participants
		5678; (4403 to 7321)	539; (391 to 742)	6835; (5080 to 9198)
Serotype 33F:1 Month after Dose 4	Number Analyzed	63 participants	71 participants	55 participants
		18997; (13140 to 27463)	658; (480 to 904)	26963; (18722 to 38830)

17. Secondary Outcome

Title	Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4
Description	Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Time Frame	1 Month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population included participants who were eligible randomized aged 2 to 6 months of age at first dose, received all 4 randomized doses with Dose 4 received within defined window 12 to 15 months of age, had at least 1 immunogenicity results within 27 to 56 days, inclusive, after Dose 4,and had no other major protocol deviations per clinician. Here, N=participants evaluable for this outcome measure and n=participants with valid results for specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		217	220	211
Measure Type: Number; Unit of Measure: Percentage of participants
Serotype 1	Number Analyzed	217 participants	220 participants	211 participants
		99.1	100.0	98.6
Serotype 3	Number Analyzed	217 participants	220 participants	211 participants
		91.7	98.6	91.5
Serotype 4	Number Analyzed	217 participants	220 participants	211 participants
		100.0	100.0	100.0
Serotype 5	Number Analyzed	217 participants	220 participants	211 participants
		99.5	100.0	99.5
Serotype 6A	Number Analyzed	217 participants	220 participants	211 participants
		100.0	100.0	100.0
Serotype 6B	Number Analyzed	216 participants	220 participants	211 participants
		100.0	100.0	100.0
Serotype 7F	Number Analyzed	217 participants	220 participants	211 participants
		99.5	100.0	100.0
Serotype 9V	Number Analyzed	217 participants	220 participants	211 participants
		99.5	100.0	100.0
Serotype 14	Number Analyzed	217 participants	220 participants	211 participants
		99.1	99.5	100.0
Serotype 18C	Number Analyzed	217 participants	220 participants	211 participants
		99.5	100.0	100.0
Serotype 19A	Number Analyzed	217 participants	219 participants	211 participants
		100.0	100.0	100.0
Serotype 19F	Number Analyzed	217 participants	220 participants	211 participants
		100.0	100.0	100.0
Serotype 23F	Number Analyzed	217 participants	220 participants	211 participants
		99.5	100.0	99.5
Serotype 8	Number Analyzed	217 participants	219 participants	211 participants
		100.0	3.2	100.0
Serotype 10A	Number Analyzed	217 participants	220 participants	211 participants
		99.1	0.9	99.5
Serotype 11A	Number Analyzed	217 participants	220 participants	211 participants
		100.0	5.9	100.0
Serotype 12F	Number Analyzed	217 participants	220 participants	211 participants
		98.2	0.0	98.6
Serotype 15B	Number Analyzed	217 participants	220 participants	211 participants
		100.0	8.6	100.0
Serotype 22F	Number Analyzed	217 participants	220 participants	211 participants
		100.0	1.8	100.0
Serotype 33F	Number Analyzed	217 participants	220 participants	211 participants
		100.0	2.7	100.0

18. Secondary Outcome

Title	Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations 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 was reported from participants in Dose 3 evaluable immunogenicity population.
Time Frame	1 Month after Dose 3 to before Dose 4

Outcome Measure Data

Analysis Population Description

Dose 3 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentration at both timepoints for the specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		218	219	212
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	218 participants	219 participants	212 participants
		0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)
Serotype 3	Number Analyzed	218 participants	219 participants	212 participants
		0.1; (0.1 to 0.1)	0.1; (0.1 to 0.1)	0.1; (0.1 to 0.1)
Serotype 4	Number Analyzed	218 participants	219 participants	212 participants
		0.3; (0.2 to 0.3)	0.2; (0.2 to 0.3)	0.3; (0.2 to 0.3)
Serotype 5	Number Analyzed	218 participants	219 participants	211 participants
		0.3; (0.2 to 0.3)	0.2; (0.2 to 0.3)	0.2; (0.2 to 0.3)
Serotype 6A	Number Analyzed	218 participants	219 participants	212 participants
		0.5; (0.4 to 0.6)	0.4; (0.4 to 0.4)	0.4; (0.3 to 0.4)
Serotype 6B	Number Analyzed	216 participants	217 participants	212 participants
		0.8; (0.6 to 0.9)	0.5; (0.4 to 0.6)	0.7; (0.6 to 0.8)
Serotype 7F	Number Analyzed	218 participants	219 participants	212 participants
		0.5; (0.4 to 0.5)	0.4; (0.4 to 0.5)	0.5; (0.4 to 0.5)
Serotype 9V	Number Analyzed	218 participants	219 participants	212 participants
		0.3; (0.2 to 0.3)	0.3; (0.2 to 0.3)	0.3; (0.2 to 0.3)
Serotype 14	Number Analyzed	217 participants	219 participants	212 participants
		0.7; (0.6 to 0.8)	0.7; (0.6 to 0.8)	0.7; (0.6 to 0.8)
Serotype 18C	Number Analyzed	218 participants	219 participants	212 participants
		0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)	0.2; (0.2 to 0.2)
Serotype 19A	Number Analyzed	218 participants	219 participants	212 participants
		0.1; (0.1 to 0.1)	0.1; (0.1 to 0.1)	0.1; (0.1 to 0.1)
Serotype 19F	Number Analyzed	218 participants	219 participants	212 participants
		0.2; (0.1 to 0.2)	0.1; (0.1 to 0.2)	0.2; (0.1 to 0.2)
Serotype 23F	Number Analyzed	218 participants	219 participants	212 participants
		0.2; (0.2 to 0.3)	0.3; (0.2 to 0.3)	0.3; (0.2 to 0.3)
Serotype 8	Number Analyzed	218 participants	216 participants	212 participants
		0.2; (0.1 to 0.2)	1.4; (1.2 to 1.6)	0.2; (0.1 to 0.2)
Serotype 10A	Number Analyzed	218 participants	219 participants	212 participants
		2.2; (1.9 to 2.6)	0.8; (0.6 to 0.9)	2.3; (1.9 to 2.7)
Serotype 11A	Number Analyzed	218 participants	219 participants	212 participants
		0.1; (0.1 to 0.2)	0.8; (0.6 to 0.9)	0.1; (0.1 to 0.2)
Serotype 12F	Number Analyzed	218 participants	219 participants	212 participants
		0.4; (0.3 to 0.5)	1.0; (0.9 to 1.1)	0.4; (0.3 to 0.4)
Serotype 15B	Number Analyzed	218 participants	219 participants	212 participants
		0.4; (0.4 to 0.5)	0.6; (0.5 to 0.7)	0.4; (0.3 to 0.4)
Serotype 22F	Number Analyzed	218 participants	219 participants	212 participants
		0.4; (0.3 to 0.4)	0.6; (0.5 to 0.8)	0.4; (0.3 to 0.4)
Serotype 33F	Number Analyzed	216 participants	219 participants	211 participants
		1.1; (0.9 to 1.2)	0.6; (0.5 to 0.7)	1.0; (0.9 to 1.2)

19. Secondary Outcome

Title	GMFR in Serotype-Specific IgG Concentrations 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 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.
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 immunogenicity populations were included. Here, "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and "Number Analyzed"= participants with valid IgG concentrations at both timepoints for the specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		218	219	212
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	216 participants	219 participants	209 participants
		2.0; (1.8 to 2.2)	2.1; (1.9 to 2.3)	2.4; (2.2 to 2.7)
Serotype 3	Number Analyzed	216 participants	219 participants	209 participants
		0.7; (0.7 to 0.8)	0.8; (0.7 to 0.9)	1.0; (0.9 to 1.1)
Serotype 4	Number Analyzed	216 participants	219 participants	209 participants
		3.9; (3.4 to 4.4)	3.4; (3.0 to 3.8)	4.3; (3.7 to 4.8)
Serotype 5	Number Analyzed	216 participants	219 participants	209 participants
		2.9; (2.6 to 3.3)	2.7; (2.4 to 3.0)	3.0; (2.6 to 3.4)
Serotype 6A	Number Analyzed	216 participants	219 participants	209 participants
		8.6; (7.5 to 9.8)	7.3; (6.5 to 8.3)	8.6; (7.6 to 9.8)
Serotype 6B	Number Analyzed	215 participants	219 participants	209 participants
		17.1; (14.3 to 20.4)	12.6; (10.8 to 14.7)	19.5; (16.2 to 23.5)
Serotype 7F	Number Analyzed	216 participants	219 participants	209 participants
		2.8; (2.6 to 3.1)	3.0; (2.7 to 3.3)	3.3; (2.9 to 3.6)
Serotype 9V	Number Analyzed	216 participants	219 participants	209 participants
		3.1; (2.8 to 3.5)	3.1; (2.8 to 3.5)	3.8; (3.4 to 4.2)
Serotype 14	Number Analyzed	215 participants	219 participants	209 participants
		2.9; (2.6 to 3.4)	3.1; (2.7 to 3.6)	3.9; (3.3 to 4.5)
Serotype 18C	Number Analyzed	216 participants	219 participants	209 participants
		2.3; (2.1 to 2.6)	2.4; (2.1 to 2.6)	2.5; (2.3 to 2.8)
Serotype 19A	Number Analyzed	216 participants	218 participants	209 participants
		3.2; (2.8 to 3.6)	2.8; (2.5 to 3.1)	3.4; (3.0 to 3.8)
Serotype 19F	Number Analyzed	216 participants	219 participants	209 participants
		3.1; (2.8 to 3.4)	2.9; (2.6 to 3.3)	3.1; (2.8 to 3.5)
Serotype 23F	Number Analyzed	216 participants	219 participants	209 participants
		5.3; (4.6 to 6.1)	5.7; (5.0 to 6.5)	5.8; (5.1 to 6.6)
Serotype 8	Number Analyzed	216 participants	217 participants	209 participants
		1.8; (1.6 to 2.0)	1.7; (1.5 to 2.0)	1.8; (1.6 to 2.0)
Serotype 10A	Number Analyzed	216 participants	219 participants	209 participants
		14.0; (11.8 to 16.5)	0.8; (0.7 to 1.0)	17.5; (14.7 to 20.7)
Serotype 11A	Number Analyzed	216 participants	219 participants	209 participants
		1.0; (0.9 to 1.1)	0.8; (0.7 to 1.0)	1.1; (1.0 to 1.2)
Serotype 12F	Number Analyzed	216 participants	219 participants	209 participants
		3.4; (3.0 to 3.9)	1.0; (1.0 to 1.1)	3.9; (3.4 to 4.4)
Serotype 15B	Number Analyzed	216 participants	219 participants	209 participants
		2.7; (2.4 to 3.1)	0.9; (0.7 to 1.1)	3.3; (2.9 to 3.7)
Serotype 22F	Number Analyzed	216 participants	219 participants	209 participants
		2.9; (2.6 to 3.1)	0.7; (0.6 to 0.9)	3.2; (2.9 to 3.6)
Serotype 33F	Number Analyzed	214 participants	219 participants	208 participants
		6.0; (5.3 to 6.7)	0.7; (0.6 to 0.9)	7.1; (6.2 to 8.1)

20. Secondary Outcome

Title	GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 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 before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.
Time Frame	From before Dose 4 to 1 Month after Dose 4

Outcome Measure Data

Analysis Population Description

Dose 4 evaluable immunogenicity population was included. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure and "Number Analyzed" =participants with valid IgG concentrations at both timepoints for the specified serotype.

Arm/Group Title		20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Arm/Group Description:		Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.	Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
Overall Number of Participants Analyzed		217	220	211
Geometric Mean (95% Confidence Interval); Unit of Measure: Fold rise
Serotype 1	Number Analyzed	217 participants	220 participants	211 participants
		10.7; (9.6 to 11.9)	12.1; (11.0 to 13.3)	12.6; (11.3 to 14.0)
Serotype 3	Number Analyzed	217 participants	220 participants	211 participants
		7.5; (6.6 to 8.4)	7.9; (7.1 to 8.8)	8.9; (8.0 to 10.0)
Serotype 4	Number Analyzed	217 participants	220 participants	211 participants
		15.0; (13.2 to 17.1)	14.3; (12.7 to 16.0)	16.5; (14.8 to 18.5)
Serotype 5	Number Analyzed	217 participants	220 participants	210 participants
		10.8; (9.8 to 12.0)	11.8; (10.7 to 13.1)	12.2; (11.0 to 13.6)
Serotype 6A	Number Analyzed	217 participants	220 participants	211 participants
		17.6; (15.7 to 19.6)	18.4; (16.6 to 20.5)	22.1; (19.8 to 24.7)
Serotype 6B	Number Analyzed	215 participants	218 participants	211 participants
		22.3; (19.9 to 24.9)	24.3; (21.9 to 27.0)	26.9; (23.9 to 30.2)
Serotype 7F	Number Analyzed	217 participants	220 participants	211 participants
		6.0; (5.5 to 6.6)	7.2; (6.5 to 8.0)	6.8; (6.2 to 7.5)
Serotype 9V	Number Analyzed	217 participants	220 participants	211 participants
		11.8; (10.5 to 13.2)	12.0; (10.8 to 13.3)	13.9; (12.4 to 15.6)
Serotype 14	Number Analyzed	217 participants	220 participants	211 participants
		4.3; (3.8 to 4.9)	4.4; (3.9 to 5.0)	5.7; (5.0 to 6.6)
Serotype 18C	Number Analyzed	217 participants	220 participants	211 participants
		11.7; (10.5 to 12.9)	14.0; (12.7 to 15.4)	12.7; (11.5 to 14.1)
Serotype 19A	Number Analyzed	217 participants	219 participants	211 participants
		34.2; (30.0 to 38.9)	37.6; (33.2 to 42.6)	38.3; (33.4 to 44.0)
Serotype 19F	Number Analyzed	217 participants	220 participants	211 participants
		18.8; (16.6 to 21.4)	21.4; (19.0 to 24.2)	19.9; (17.6 to 22.4)
Serotype 23F	Number Analyzed	217 participants	220 participants	211 participants
		22.6; (20.1 to 25.5)	22.6; (19.8 to 25.7)	22.7; (20.1 to 25.7)
Serotype 8	Number Analyzed	217 participants	218 participants	211 participants
		10.8; (9.6 to 12.1)	1.3; (1.2 to 1.4)	11.2; (9.9 to 12.7)
Serotype 10A	Number Analyzed	217 participants	220 participants	211 participants
		6.3; (5.6 to 7.1)	1.1; (1.0 to 1.1)	7.4; (6.6 to 8.3)
Serotype 11A	Number Analyzed	217 participants	220 participants	211 participants
		7.0; (6.2 to 7.9)	1.1; (1.0 to 1.2)	8.1; (7.2 to 9.1)
Serotype 12F	Number Analyzed	217 participants	220 participants	211 participants
		8.5; (7.6 to 9.4)	1.0; (1.0 to 1.1)	9.9; (8.9 to 10.9)
Serotype 15B	Number Analyzed	217 participants	220 participants	211 participants
		6.8; (6.0 to 7.7)	1.5; (1.3 to 1.6)	8.7; (7.6 to 10.0)
Serotype 22F	Number Analyzed	217 participants	220 participants	211 participants
		7.9; (7.1 to 8.8)	1.2; (1.1 to 1.3)	8.9; (8.1 to 9.9)
Serotype 33F	Number Analyzed	217 participants	220 participants	211 participants
		5.7; (5.1 to 6.3)	1.2; (1.1 to 1.3)	6.9; (6.2 to 7.8)

Adverse Events

Time Frame	LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (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 event may appear as both an AE and a SAE. However, what is 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 (SC)		13vPnC (SC)		20vPnC (IM)
Arm/Group Description	Participants received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.		Participants received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.		Participants received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Participants completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.
All-Cause Mortality
	20vPnC (SC)		13vPnC (SC)		20vPnC (IM)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/225 (0.00%)		0/224 (0.00%)		1/217 (0.46%)
Serious Adverse Events
	20vPnC (SC)		13vPnC (SC)		20vPnC (IM)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/225 (6.22%)		9/224 (4.02%)		16/217 (7.37%)
Cardiac disorders
Cardio-respiratory arrest * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Congenital, familial and genetic disorders
Congenital mitral valve incompetence * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
Laryngomalacia * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Patent ductus arteriosus * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
General disorders
Pyrexia * 1	1/225 (0.44%)	1	0/224 (0.00%)	0	2/217 (0.92%)	2
Immune system disorders
Food allergy * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Milk allergy * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
Infections and infestations
Asymptomatic COVID-19 * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Bronchiolitis * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
Bronchitis * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
Cellulitis orbital * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Croup infectious * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Exanthema subitum * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Infectious mononucleosis * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	0/217 (0.00%)	0
Pharyngitis * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	1/217 (0.46%)	1
Pneumonia * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Pneumonia bacterial * 1	0/225 (0.00%)	0	1/224 (0.45%)	1	1/217 (0.46%)	1
Pneumonia respiratory syncytial viral * 1	1/225 (0.44%)	1	1/224 (0.45%)	1	0/217 (0.00%)	0
Pyelonephritis acute * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Respiratory syncytial virus bronchiolitis * 1	4/225 (1.78%)	4	2/224 (0.89%)	2	1/217 (0.46%)	1
Respiratory syncytial virus infection * 1	4/225 (1.78%)	4	1/224 (0.45%)	1	1/217 (0.46%)	1
Urinary tract infection * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	2/217 (0.92%)	2
Injury, poisoning and procedural complications
Burns second degree * 1	1/225 (0.44%)	1	0/224 (0.00%)	0	0/217 (0.00%)	0
Clavicle fracture * 1	1/225 (0.44%)	1	0/224 (0.00%)	0	0/217 (0.00%)	0
Near drowning * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Nervous system disorders
Febrile convulsion * 1	2/225 (0.89%)	2	0/224 (0.00%)	0	0/217 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/225 (0.44%)	1	1/224 (0.45%)	1	1/217 (0.46%)	1
Skin and subcutaneous tissue disorders
Tuberculid * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
Vascular disorders
Kawasaki's disease * 1	0/225 (0.00%)	0	0/224 (0.00%)	0	1/217 (0.46%)	1
1 Term from vocabulary, MedDRA 24.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	20vPnC (SC)		13vPnC (SC)		20vPnC (IM)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	222/225 (98.67%)		223/224 (99.55%)		211/217 (97.24%)
General disorders
Injection site erythema (REDNESS) † 1	217/225 (96.44%)	762	217/224 (96.88%)	784	130/217 (59.91%)	297
Injection site pain (PAIN) † 1	84/225 (37.33%)	167	85/224 (37.95%)	166	65/217 (29.95%)	118
Injection site swelling (SWELLING) † 1	206/225 (91.56%)	723	211/224 (94.20%)	729	119/217 (54.84%)	251
Pyrexia (FEVER) † 1	136/225 (60.44%)	219	135/224 (60.27%)	219	110/217 (50.69%)	197
Infections and infestations
Bronchitis * 1	8/225 (3.56%)	10	8/224 (3.57%)	9	11/217 (5.07%)	11
Nasopharyngitis * 1	49/225 (21.78%)	72	64/224 (28.57%)	85	66/217 (30.41%)	96
Upper respiratory tract infection * 1	12/225 (5.33%)	22	8/224 (3.57%)	10	8/217 (3.69%)	14
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE) † 1	62/225 (27.56%)	99	68/224 (30.36%)	118	55/217 (25.35%)	94
Nervous system disorders
Hypersomnia (INCREASED SLEEP) † 1	147/225 (65.33%)	343	161/224 (71.88%)	410	154/217 (70.97%)	389
Psychiatric disorders
Irritability (IRRITABILITY) † 1	110/225 (48.89%)	291	119/224 (53.13%)	295	107/217 (49.31%)	282
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation * 1	18/225 (8.00%)	22	11/224 (4.91%)	14	15/217 (6.91%)	19
Skin and subcutaneous tissue disorders
Eczema infantile * 1	6/225 (2.67%)	6	16/224 (7.14%)	18	13/217 (5.99%)	14
Eczema * 1	22/225 (9.78%)	25	19/224 (8.48%)	19	32/217 (14.75%)	33
1 Term from vocabulary, MedDRA 24.1; † 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 the 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: NCT04530838
• Other Study ID Numbers: B7471016; 2022-001146-38 ( EudraCT Number )
• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Results First Submitted: March 30, 2023
• Results First Posted: April 21, 2023
• Last Update Posted: April 21, 2023