A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

• ClinicalTrials.gov Identifier: NCT03571607
• Recruitment Status: Completed
• First Posted: June 27, 2018
• Results First Posted: December 10, 2019
• Last Update Posted: February 18, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Pneumococcal Infections
• Intervention: Biological: 13-valent pneumococcal conjugate vaccine
• Enrollment: 206

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years
Arm/Group Description	Participants aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly on Day 1.	Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Period Title: Overall Study
Started	53	153
Vaccinated	53	153
Completed	53	153
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	Total
Arm/Group Description		Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.	Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.	Total of all reporting groups
Overall Number of Baseline Participants		53	153	206
Baseline Analysis Population Description		Safety analysis set included all participants who received 1 dose of study vaccine.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	53 participants	153 participants	206 participants
		12.7 (2.66)	49.0 (10.12)	39.6 (18.18)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	153 participants	206 participants
	Female	22 41.5%	77 50.3%	99 48.1%
	Male	31 58.5%	76 49.7%	107 51.9%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	53 participants	153 participants	206 participants
Asian		53	153	206
Non-Hispanic/non-Latino/not of Spanish origin		53	153	206

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Description	Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm) for participants aged 6 to <12 years, and as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm) for participants aged 12 to <18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time Frame	Day 1 up to Day 7

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.

Arm/Group Title		13vPnC: 6 to <18 Years
Arm/Group Description:		Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		53
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Redness: Any	Number Analyzed	47 participants
		21.3; (10.7 to 35.7)
Redness: Mild	Number Analyzed	47 participants
		10.6; (3.5 to 23.1)
Redness: Moderate	Number Analyzed	47 participants
		10.6; (3.5 to 23.1)
Redness: Severe	Number Analyzed	47 participants
		0.0; (0.0 to 7.5)
Swelling: Any	Number Analyzed	47 participants
		34.0; (20.9 to 49.3)
Swelling: Mild	Number Analyzed	47 participants
		14.9; (6.2 to 28.3)
Swelling: Moderate	Number Analyzed	47 participants
		17.0; (7.6 to 30.8)
Swelling: Severe	Number Analyzed	47 participants
		2.1; (0.1 to 11.3)
Pain at the injection site: Any	Number Analyzed	52 participants
		78.8; (65.3 to 88.9)
Pain at the injection site: Mild	Number Analyzed	52 participants
		57.7; (43.2 to 71.3)
Pain at the injection site: Moderate	Number Analyzed	52 participants
		21.2; (11.1 to 34.7)
Pain at the injection site: Severe	Number Analyzed	52 participants
		0.0; (0.0 to 6.8)

2. Primary Outcome

Title	Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Description	Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time Frame	Day 1 up to Day 14

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.

Arm/Group Title		13vPnC: 18 to <65 Years
Arm/Group Description:		Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		153
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Redness: Any	Number Analyzed	135 participants
		7.4; (3.6 to 13.2)
Redness: Mild	Number Analyzed	135 participants
		5.2; (2.1 to 10.4)
Redness: Moderate	Number Analyzed	135 participants
		2.2; (0.5 to 6.4)
Redness: Severe	Number Analyzed	135 participants
		0.0; (0.0 to 2.7)
Swelling: Any	Number Analyzed	136 participants
		12.5; (7.5 to 19.3)
Swelling: Mild	Number Analyzed	136 participants
		5.1; (2.1 to 10.3)
Swelling: Moderate	Number Analyzed	136 participants
		7.4; (3.6 to 13.1)
Swelling: Severe	Number Analyzed	136 participants
		0.0; (0.0 to 2.7)
Pain at the injection site: Any	Number Analyzed	145 participants
		66.2; (57.9 to 73.8)
Pain at the injection site: Mild	Number Analyzed	145 participants
		53.8; (45.3 to 62.1)
Pain at the injection site: Moderate	Number Analyzed	145 participants
		11.0; (6.4 to 17.3)
Pain at the injection site: Severe	Number Analyzed	145 participants
		1.4; (0.2 to 4.9)

3. Primary Outcome

Title	Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years
Description	Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to [>=] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Time Frame	Day 1 up to Day 7

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.

Arm/Group Title		13vPnC: 6 to <18 Years
Arm/Group Description:		Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		53
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Fever: 37.5 degree C to 38.4 degree C	Number Analyzed	48 participants
		12.5; (4.7 to 25.2)
Fever: 38.5 degree C to 38.9 degree C	Number Analyzed	48 participants
		2.1; (0.1 to 11.1)
Fever: 39.0 degree C to 40.0 degree C	Number Analyzed	48 participants
		0.0; (0.0 to 7.4)
Fever: >40.0 degree C	Number Analyzed	48 participants
		0.0; (0.0 to 7.4)
Fatigue: Any	Number Analyzed	48 participants
		37.5; (24.0 to 52.6)
Fatigue: Mild	Number Analyzed	48 participants
		25.0; (13.6 to 39.6)
Fatigue: Moderate	Number Analyzed	48 participants
		10.4; (3.5 to 22.7)
Fatigue: Severe	Number Analyzed	48 participants
		2.1; (0.1 to 11.1)
Headache: Any	Number Analyzed	49 participants
		24.5; (13.3 to 38.9)
Headache: Mild	Number Analyzed	49 participants
		16.3; (7.3 to 29.7)
Headache: Moderate	Number Analyzed	49 participants
		6.1; (1.3 to 16.9)
Headache: Severe	Number Analyzed	49 participants
		2.0; (0.1 to 10.9)
Vomiting: Any	Number Analyzed	47 participants
		0.0; (0.0 to 7.5)
Vomiting: Mild	Number Analyzed	47 participants
		0.0; (0.0 to 7.5)
Vomiting: Moderate	Number Analyzed	47 participants
		0.0; (0.0 to 7.5)
Vomiting: Severe	Number Analyzed	47 participants
		0.0; (0.0 to 7.5)
Diarrhea: Any	Number Analyzed	48 participants
		8.3; (2.3 to 20.0)
Diarrhea: Mild	Number Analyzed	48 participants
		8.3; (2.3 to 20.0)
Diarrhea: Moderate	Number Analyzed	48 participants
		0.0; (0.0 to 7.4)
Diarrhea: Severe	Number Analyzed	48 participants
		0.0; (0.0 to 7.4)
Muscle pain: Any	Number Analyzed	49 participants
		30.6; (18.3 to 45.4)
Muscle pain: Mild	Number Analyzed	49 participants
		26.5; (14.9 to 41.1)
Muscle pain: Moderate	Number Analyzed	49 participants
		4.1; (0.5 to 14.0)
Muscle pain: Severe	Number Analyzed	49 participants
		0.0; (0.0 to 7.3)
Joint pain: Any	Number Analyzed	48 participants
		6.3; (1.3 to 17.2)
Joint pain: Mild	Number Analyzed	48 participants
		4.2; (0.5 to 14.3)
Joint pain: Moderate	Number Analyzed	48 participants
		2.1; (0.1 to 11.1)
Joint pain: Severe	Number Analyzed	48 participants
		0.0; (0.0 to 7.4)
Use of antipyretic or pain medication	Number Analyzed	47 participants
		6.4; (1.3 to 17.5)

4. Primary Outcome

Title	Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years
Description	Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).
Time Frame	Day 1 up to Day 14

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category.

Arm/Group Title		13vPnC: 18 to <65 Years
Arm/Group Description:		Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		153
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Fever: 37.5 degree C to 38.4 degree C	Number Analyzed	134 participants
		6.0; (2.6 to 11.4)
Fever: 38.5 degree C to 38.9 degree C	Number Analyzed	134 participants
		0.0; (0.0 to 2.7)
Fever: 39.0 degree C to 40.0 degree C	Number Analyzed	134 participants
		0.0; (0.0 to 2.7)
Fever: >40.0 degree C	Number Analyzed	134 participants
		0.0; (0.0 to 2.7)
Fatigue: Any	Number Analyzed	142 participants
		33.1; (25.4 to 41.5)
Fatigue: Mild	Number Analyzed	142 participants
		25.4; (18.4 to 33.3)
Fatigue: Moderate	Number Analyzed	142 participants
		7.7; (3.9 to 13.4)
Fatigue: Severe	Number Analyzed	142 participants
		0.0; (0.0 to 2.6)
Headache: Any	Number Analyzed	141 participants
		23.4; (16.7 to 31.3)
Headache: Mild	Number Analyzed	141 participants
		19.1; (13.0 to 26.6)
Headache: Moderate	Number Analyzed	141 participants
		4.3; (1.6 to 9.0)
Headache: Severe	Number Analyzed	141 participants
		0.0; (0.0 to 2.6)
Vomiting: Any	Number Analyzed	136 participants
		1.5; (0.2 to 5.2)
Vomiting: Mild	Number Analyzed	136 participants
		1.5; (0.2 to 5.2)
Vomiting: Moderate	Number Analyzed	136 participants
		0.0; (0.0 to 2.7)
Vomiting: Severe	Number Analyzed	136 participants
		0.0; (0.0 to 2.7)
Diarrhea: Any	Number Analyzed	141 participants
		18.4; (12.4 to 25.8)
Diarrhea: Mild	Number Analyzed	141 participants
		15.6; (10.0 to 22.7)
Diarrhea: Moderate	Number Analyzed	141 participants
		2.1; (0.4 to 6.1)
Diarrhea: Severe	Number Analyzed	141 participants
		0.7; (0.0 to 3.9)
Muscle pain: Any	Number Analyzed	139 participants
		27.3; (20.1 to 35.5)
Muscle pain: Mild	Number Analyzed	139 participants
		20.9; (14.4 to 28.6)
Muscle pain: Moderate	Number Analyzed	139 participants
		5.8; (2.5 to 11.0)
Muscle pain: Severe	Number Analyzed	139 participants
		0.7; (0.0 to 3.9)
Joint pain: Any	Number Analyzed	138 participants
		13.8; (8.5 to 20.7)
Joint pain: Mild	Number Analyzed	138 participants
		9.4; (5.1 to 15.6)
Joint pain: Moderate	Number Analyzed	138 participants
		3.6; (1.2 to 8.3)
Joint pain: Severe	Number Analyzed	138 participants
		0.7; (0.0 to 4.0)
Use of antipyretic or pain medication	Number Analyzed	134 participants
		8.2; (4.2 to 14.2)

5. Primary Outcome

Title	Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Time Frame	signing of informed consent form (Day 1) up to Day 43

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received 1 dose of study vaccine.

Arm/Group Title	13vPnC: All Participants
Arm/Group Description:	All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed	206
Measure Type: Number; Unit of Measure: percentage of participants
AEs	16
SAEs	0

6. Secondary Outcome

Title	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination
Description	Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution.
Time Frame	Pre-vaccination and 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity population: eligible participants who received the study vaccine and took no prohibited vaccines, had blood drawn within 1 month after vaccination with at least 1 valid and determinate assay and had no major protocol violations. Here, "Number analyzed" signifies participants evaluable for each specified row.

Arm/Group Title		13vPnC: All Participants
Arm/Group Description:		All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		206
Geometric Mean (95% Confidence Interval); Unit of Measure: titers
Pre-vaccination; Serotype 1	Number Analyzed	202 participants
		10; (9.2 to 10.2)
1 month after vaccination; Serotype 1	Number Analyzed	201 participants
		152; (119.2 to 193.8)
Pre-vaccination; Serotype 3	Number Analyzed	205 participants
		11; (9.8 to 13.1)
1 month after vaccination; Serotype 3	Number Analyzed	203 participants
		63; (52.6 to 75.8)
Pre-vaccination; Serotype 4	Number Analyzed	195 participants
		18; (14.5 to 22.1)
1 month after vaccination; Serotype 4	Number Analyzed	203 participants
		1257; (896.0 to 1763.8)
Pre-vaccination; Serotype 5	Number Analyzed	200 participants
		16; (15.3 to 17.5)
1 month after vaccination; Serotype 5	Number Analyzed	199 participants
		185; (143.9 to 237.5)
Pre-vaccination; Serotype 6A	Number Analyzed	171 participants
		57; (44.1 to 74.9)
1 month after vaccination; Serotype 6A	Number Analyzed	197 participants
		2487; (1811.7 to 3415.0)
Pre-vaccination; Serotype 6B	Number Analyzed	179 participants
		72; (56.3 to 93.0)
1 month after vaccination; Serotype 6B	Number Analyzed	198 participants
		1845; (1405.9 to 2421.9)
Pre-vaccination; Serotype 7F	Number Analyzed	190 participants
		167; (137.0 to 203.3)
1 month after vaccination; Serotype 7F	Number Analyzed	202 participants
		2107; (1752.6 to 2532.5)
Pre-vaccination; Serotype 9V	Number Analyzed	192 participants
		204; (166.6 to 249.7)
1 month after vaccination; Serotype 9V	Number Analyzed	199 participants
		1425; (1134.4 to 1789.8)
Pre-vaccination; Serotype 14	Number Analyzed	191 participants
		129; (97.9 to 171.1)
1 month after vaccination; Serotype 14	Number Analyzed	200 participants
		1919; (1518.8 to 2424.0)
Pre-vaccination; Serotype 18C	Number Analyzed	191 participants
		61; (46.3 to 81.0)
1 month after vaccination; Serotype 18C	Number Analyzed	199 participants
		1829; (1390.8 to 2405.1)
Pre-vaccination; Serotype 19A	Number Analyzed	202 participants
		38; (29.9 to 47.8)
1 month after vaccination; Serotype 19A	Number Analyzed	203 participants
		955; (745.6 to 1223.2)
Pre-vaccination; Serotype 19F	Number Analyzed	198 participants
		42; (34.8 to 50.4)
1 month after vaccination; Serotype 19F	Number Analyzed	197 participants
		1126; (849.5 to 1493.4)
Pre-vaccination; Serotype 23F	Number Analyzed	201 participants
		14; (11.1 to 17.2)
1 month after vaccination; Serotype 23F	Number Analyzed	202 participants
		713; (506.7 to 1001.9)

7. Secondary Outcome

Title	Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination
Description	OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Time Frame	Pre-vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity set: Eligible participants received study vaccine,took no prohibited vaccine,had blood drawn in specified time frame had atleast 1 valid,determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination,no major protocol violation. Number analyzed=participant evaluable for specified row.

Arm/Group Title		13vPnC: All Participants
Arm/Group Description:		All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed		206
Geometric Mean (95% Confidence Interval); Unit of Measure: fold rise
Serotype 1	Number Analyzed	200 participants
		15.6; (12.33 to 19.82)
Serotype 3	Number Analyzed	202 participants
		5.5; (4.59 to 6.54)
Serotype 4	Number Analyzed	192 participants
		61.7; (42.80 to 88.99)
Serotype 5	Number Analyzed	195 participants
		11.2; (8.69 to 14.34)
Serotype 6A	Number Analyzed	167 participants
		34.7; (24.39 to 49.44)
Serotype 6B	Number Analyzed	174 participants
		21.9; (15.71 to 30.51)
Serotype 7F	Number Analyzed	188 participants
		12.1; (9.84 to 14.76)
Serotype 9V	Number Analyzed	188 participants
		6.8; (5.36 to 8.62)
Serotype 14	Number Analyzed	186 participants
		13.2; (9.63 to 18.04)
Serotype 18C	Number Analyzed	186 participants
		26.7; (19.39 to 36.86)
Serotype 19A	Number Analyzed	199 participants
		24.9; (19.05 to 32.66)
Serotype 19F	Number Analyzed	192 participants
		26.6; (19.89 to 35.63)
Serotype 23F	Number Analyzed	200 participants
		50.4; (35.70 to 71.16)

8. Secondary Outcome

Title	Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
Description	Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution.
Time Frame	Pre-vaccination and 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.

Arm/Group Title	13vPnC: All Participants
Arm/Group Description:	All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed	206
Geometric Mean (95% Confidence Interval); Unit of Measure: microgram per milliliter (mcg/mL)
Pre-vaccination; Serotype 1	0.132; (0.109 to 0.161)
1 month after vaccination; Serotype 1	4.427; (3.423 to 5.726)
Pre-vaccination; Serotype 3	0.115; (0.094 to 0.141)
1 month after vaccination; Serotype 3	0.531; (0.437 to 0.646)
Pre-vaccination; Serotype 4	0.055; (0.045 to 0.068)
1 month after vaccination; Serotype 4	1.826; (1.387 to 2.404)
Pre-vaccination; Serotype 5	0.058; (0.046 to 0.075)
1 month after vaccination; Serotype 5	2.779; (1.972 to 3.915)
Pre-vaccination; Serotype 6A	0.173; (0.133 to 0.224)
1 month after vaccination; Serotype 6A	4.070; (2.915 to 5.684)
Pre-vaccination; Serotype 6B	0.105; (0.080 to 0.138)
1 month after vaccination; Serotype 6B	2.354; (1.631 to 3.396)
Pre-vaccination; Serotype 7F	0.117; (0.092 to 0.150)
1 month after vaccination; Serotype 7F	4.670; (3.629 to 6.010)
Pre-vaccination; Serotype 9V	0.067; (0.054 to 0.082)
1 month after vaccination; Serotype 9V	1.483; (1.131 to 1.944)
Pre-vaccination; Serotype 14	0.335; (0.252 to 0.447)
1 month after vaccination; Serotype 14	7.769; (5.844 to 10.328)
Pre-vaccination; Serotype 18C	0.168; (0.131 to 0.216)
1 month after vaccination; Serotype 18C	5.187; (4.026 to 6.682)
Pre-vaccination; Serotype 19A	0.496; (0.391 to 0.629)
1 month after vaccination; Serotype 19A	7.616; (5.786 to 10.026)
Pre-vaccination; Serotype 19F	0.217; (0.171 to 0.275)
1 month after vaccination; Serotype 19F	4.315; (3.241 to 5.744)
Pre-vaccination; Serotype 23F	0.181; (0.143 to 0.228)
1 month after vaccination; Serotype 23F	6.283; (4.524 to 8.727)

9. Secondary Outcome

Title	GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
Description	IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.
Time Frame	Pre- vaccination to 1 month after vaccination

Outcome Measure Data

Analysis Population Description

Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.

Arm/Group Title	13vPnC: All Participants
Arm/Group Description:	All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
Overall Number of Participants Analyzed	206
Geometric Mean (95% Confidence Interval); Unit of Measure: fold rise
Serotype 1	33.445; (26.374 to 42.413)
Serotype 3	4.605; (3.839 to 5.524)
Serotype 4	32.960; (25.331 to 42.886)
Serotype 5	47.565; (36.867 to 61.368)
Serotype 6A	23.587; (18.010 to 30.890)
Serotype 6B	22.421; (17.045 to 29.493)
Serotype 7F	39.843; (31.473 to 50.438)
Serotype 9V	22.232; (17.426 to 28.362)
Serotype 14	23.161; (17.179 to 31.227)
Serotype 18C	30.833; (24.008 to 39.597)
Serotype 19A	15.354; (12.116 to 19.459)
Serotype 19F	19.892; (15.552 to 25.443)
Serotype 23F	34.809; (26.436 to 45.833)

Adverse Events

Time Frame	signing of informed consent form (Day 1) up to Day 43
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	13vPnC: All Participants
Arm/Group Description	Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.	Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.	All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
All-Cause Mortality
	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	13vPnC: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/53 (0.00%)	0/153 (0.00%)	0/206 (0.00%)
Serious Adverse Events
	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	13vPnC: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/53 (0.00%)	0/153 (0.00%)	0/206 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	13vPnC: All Participants
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	49/53 (92.45%)	121/153 (79.08%)	170/206 (82.52%)
Ear and labyrinth disorders
Tinnitus * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Gastrointestinal disorders
Diarrhoea † 1 [1]	4/48 (8.33%)	26/141 (18.44%)	30/189 (15.87%)
Vomiting † 1 [1]	0/47 (0.00%)	2/136 (1.47%)	2/183 (1.09%)
Enteritis * 1	1/53 (1.89%)	0/153 (0.00%)	1/206 (0.49%)
General disorders
Fatigue † 1 [1]	18/48 (37.50%)	47/142 (33.10%)	65/190 (34.21%)
Redness † 1 [1]	10/47 (21.28%)	10/135 (7.41%)	20/182 (10.99%)
Injection site erythema * 1	1/53 (1.89%)	0/153 (0.00%)	1/206 (0.49%)
Pain at the injection site † 1 [1]	41/52 (78.85%)	96/145 (66.21%)	137/197 (69.54%)
Injection site pain * 1	1/53 (1.89%)	2/153 (1.31%)	3/206 (1.46%)
Injection site swelling † 1 [1]	16/47 (34.04%)	17/136 (12.50%)	33/183 (18.03%)
Pyrexia † 1 [1]	7/48 (14.58%)	8/134 (5.97%)	15/182 (8.24%)
Infections and infestations
Bronchitis * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Conjunctivitis * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Gastroenteritis * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Herpes zoster * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Nasopharyngitis * 1	1/53 (1.89%)	8/153 (5.23%)	9/206 (4.37%)
Pharyngitis * 1	3/53 (5.66%)	2/153 (1.31%)	5/206 (2.43%)
Upper respiratory tract infection * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Injury, poisoning and procedural complications
Fall * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Wrist fracture * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Metabolism and nutrition disorders
Decreased appetite * 1	1/53 (1.89%)	0/153 (0.00%)	1/206 (0.49%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1 [1]	3/48 (6.25%)	19/138 (13.77%)	22/186 (11.83%)
Back pain * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Myalgia † 1 [1]	15/49 (30.61%)	38/139 (27.34%)	53/188 (28.19%)
Pain in extremity * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Nervous system disorders
Dizziness * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Headache † 1 [1]	12/49 (24.49%)	33/141 (23.40%)	45/190 (23.68%)
Psychiatric disorders
Middle insomnia * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	1/53 (1.89%)	0/153 (0.00%)	1/206 (0.49%)
Hyperventilation * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Skin and subcutaneous tissue disorders
Pruritus * 1	0/53 (0.00%)	1/153 (0.65%)	1/206 (0.49%)
Rash papular * 1	1/53 (1.89%)	0/153 (0.00%)	1/206 (0.49%)
1 Term from vocabulary, MedDRA 21.1; * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment; [1] Number of participants at risk = number of participants evaluable for the adverse event.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

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

Results Point of Contact

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yamazaki Y, Ikeda M, Imada T, Furuno K, Mizukami T, de Solom R, Shoji Y, Oe M, Aizawa M, Giardina PC, Schmoele-Thoma B, Scott DA. A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines. Vaccine. 2021 Oct 15;39(43):6414-6421. doi: 10.1016/j.vaccine.2021.08.106. Epub 2021 Sep 23.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03571607
• Other Study ID Numbers: B1851172; 2018-003054-24 ( EudraCT Number )
• First Submitted: June 20, 2018
• First Posted: June 27, 2018
• Results First Submitted: November 20, 2019
• Results First Posted: December 10, 2019
• Last Update Posted: February 18, 2020