Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years (NCT NCT00562354)

Last Updated: 2011-11-11

Results Overview

Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

271 participants

Primary outcome timeframe

1 month after vaccination

Results posted on

2011-11-11

Participant Flow

271 participants were enrolled; 270 were vaccinated with study vaccine.

Participant milestones

Participant milestones
Measure	13vPnC (50 to 64 Years of Age) 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Overall Study STARTED	134	137
Overall Study Received Study Treatment	134	136
Overall Study Evaluable Immunogenicity Population	134	134
Overall Study COMPLETED	134	135
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC (50 to 64 Years of Age) 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC (50 to 64 Years of Age) n=134 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.	Total n=268 Participants Total of all reporting groups
Age Continuous	57.5 years STANDARD_DEVIATION 4.0 • n=93 Participants	70.5 years STANDARD_DEVIATION 4.4 • n=4 Participants	64.0 years STANDARD_DEVIATION 7.7 • n=27 Participants
Sex: Female, Male Female	76 Participants n=93 Participants	70 Participants n=4 Participants	146 Participants n=27 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	64 Participants n=4 Participants	122 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=263 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	62 titer Interval 53.1 to 73.4	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	1333 titer Interval 1054.4 to 1684.2	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	215 titer Interval 172.0 to 269.2	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	2256 titer Interval 1884.4 to 2700.3	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	2861 titer Interval 2406.4 to 3401.1	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	863 titer Interval 652.9 to 1141.5	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	1494 titer Interval 1267.1 to 1761.9	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	2082 titer Interval 1683.5 to 2575.0	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	821 titer Interval 655.7 to 1027.8	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	538 titer Interval 415.9 to 696.7	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	124 titer Interval 101.5 to 150.7	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	1793 titer Interval 1476.1 to 2177.7	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	874 titer Interval 729.0 to 1047.8	—

PRIMARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.

Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	93 titer Interval 70.3 to 124.2	162 titer Interval 124.0 to 212.6
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	53 titer Interval 42.0 to 67.8	73 titer Interval 58.6 to 90.9
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	1209 titer Interval 830.1 to 1762.2	1464 titer Interval 1098.8 to 1950.9
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	159 titer Interval 113.6 to 221.2	289 titer Interval 214.7 to 387.9
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	1667 titer Interval 1283.1 to 2165.9	3082 titer Interval 2431.0 to 3908.2
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	2556 titer Interval 1967.1 to 3320.8	3182 titer Interval 2527.6 to 4004.7
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	1469 titer Interval 1075.6 to 2005.6	2218 titer Interval 1772.6 to 2776.3
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	738 titer Interval 497.8 to 1094.8	1007 titer Interval 675.2 to 1501.7
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	1294 titer Interval 1027.3 to 1629.2	1726 titer Interval 1362.8 to 2185.2
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	1503 titer Interval 1087.0 to 2078.8	2862 titer Interval 2187.0 to 3745.6
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	361 titer Interval 243.9 to 533.2	788 titer Interval 566.6 to 1097.2
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	616 titer Interval 488.1 to 776.7	1241 titer Interval 949.3 to 1621.7
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	614 titer Interval 438.9 to 858.0	1083 titer Interval 804.7 to 1458.5

PRIMARY outcome

Timeframe: Prevaccination (Day 1), 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.

Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=263 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 1	23.3 fold rise Interval 19.17 to 28.31	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 3	11.5 fold rise Interval 9.69 to 13.67	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 4	79.6 fold rise Interval 55.79 to 113.47	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 5	42.4 fold rise Interval 33.64 to 53.51	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 6A	48.8 fold rise Interval 35.04 to 67.87	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 6B	16.6 fold rise Interval 11.79 to 23.51	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 7F	137.2 fold rise Interval 99.26 to 189.69	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 9V	13.4 fold rise Interval 9.17 to 19.46	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 14	12.4 fold rise Interval 9.23 to 16.76	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 18C	52.9 fold rise Interval 38.41 to 72.82	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 19A	41.9 fold rise Interval 32.46 to 54.22	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 19F	42.7 fold rise Interval 32.34 to 56.25	—
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population Serotype 23F	47.5 fold rise Interval 35.23 to 63.92	—

PRIMARY outcome

Timeframe: Prevaccination (Day 1), 1 month after vaccination

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	11.2 fold rise Interval 6.98 to 18.09	24.1 fold rise Interval 14.68 to 39.6
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	18.7 fold rise Interval 14.02 to 24.91	28.8 fold rise Interval 22.17 to 37.52
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	9.8 fold rise Interval 7.62 to 12.49	13.6 fold rise Interval 10.66 to 17.24
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	50.7 fold rise Interval 29.4 to 87.32	123.3 fold rise Interval 78.54 to 193.67
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	34.3 fold rise Interval 24.61 to 47.9	52.0 fold rise Interval 37.59 to 71.88
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	32.3 fold rise Interval 20.5 to 50.81	74.7 fold rise Interval 46.39 to 120.22
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	99.9 fold rise Interval 62.24 to 160.4	192.5 fold rise Interval 124.26 to 298.35
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	7.3 fold rise Interval 4.42 to 12.02	24.2 fold rise Interval 14.02 to 41.86
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	10.6 fold rise Interval 7.0 to 16.08	14.6 fold rise Interval 9.46 to 22.44
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	31.0 fold rise Interval 19.68 to 48.75	89.2 fold rise Interval 57.54 to 138.25
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	25.3 fold rise Interval 18.75 to 34.13	69.5 fold rise Interval 46.56 to 103.89
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	25.3 fold rise Interval 17.42 to 36.65	70.3 fold rise Interval 47.39 to 104.14
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	40.8 fold rise Interval 26.53 to 62.89	54.7 fold rise Interval 36.11 to 82.94

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.

Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 1	93 titer Interval 70.3 to 124.2	164 titer Interval 125.1 to 213.9
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 3	54 titer Interval 42.2 to 67.9	73 titer Interval 58.6 to 90.2
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 4	1331 titer Interval 967.6 to 1831.7	1786 titer Interval 1390.9 to 2293.9
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 5	171 titer Interval 123.9 to 236.4	294 titer Interval 219.9 to 393.0
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6A	1663 titer Interval 1287.0 to 2147.9	3148 titer Interval 2502.2 to 3960.6
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6B	2462 titer Interval 1905.0 to 3181.7	3383 titer Interval 2721.3 to 4204.8
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 7F	1484 titer Interval 1097.7 to 2005.3	2247 titer Interval 1818.6 to 2776.7
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 9V	797 titer Interval 557.1 to 1138.9	1062 titer Interval 735.5 to 1533.7
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 14	1289 titer Interval 1033.8 to 1608.1	1740 titer Interval 1386.0 to 2183.8
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 18C	1530 titer Interval 1114.5 to 2099.8	2922 titer Interval 2243.8 to 3804.0
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19A	604 titer Interval 483.8 to 754.4	1267 titer Interval 979.8 to 1637.9
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19F	627 titer Interval 454.7 to 863.7	1094 titer Interval 814.1 to 1470.4
Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 23F	398 titer Interval 276.1 to 575.1	824 titer Interval 596.3 to 1137.5

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=266 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	98.9 percentage of participants Interval 96.7 to 99.8	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	91.6 percentage of participants Interval 87.6 to 94.7	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	89.8 percentage of participants Interval 85.6 to 93.2	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	95.2 percentage of participants Interval 91.8 to 97.5	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	88.6 percentage of participants Interval 84.0 to 92.2	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	98.5 percentage of participants Interval 96.2 to 99.6	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	98.5 percentage of participants Interval 96.2 to 99.6	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	96.5 percentage of participants Interval 93.5 to 98.4	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	89.1 percentage of participants Interval 84.7 to 92.5	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	98.5 percentage of participants Interval 96.2 to 99.6	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	96.6 percentage of participants Interval 93.7 to 98.4	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	94.2 percentage of participants Interval 90.6 to 96.7	—
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	89.2 percentage of participants Interval 84.8 to 92.7	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	89.1 percentage of participants Interval 82.5 to 93.9	94.0 percentage of participants Interval 88.6 to 97.4
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	87.9 percentage of participants Interval 81.1 to 92.9	91.8 percentage of participants Interval 85.8 to 95.8
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	93.5 percentage of participants Interval 87.6 to 97.2	96.9 percentage of participants Interval 92.3 to 99.1
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	85.8 percentage of participants Interval 78.5 to 91.4	91.3 percentage of participants Interval 85.0 to 95.6
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	97.7 percentage of participants Interval 93.5 to 99.5	99.2 percentage of participants Interval 95.9 to 100.0
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	97.7 percentage of participants Interval 93.4 to 99.5	99.3 percentage of participants Interval 95.9 to 100.0
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	93.9 percentage of participants Interval 88.4 to 97.3	99.2 percentage of participants Interval 95.7 to 100.0
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	88.6 percentage of participants Interval 82.0 to 93.5	89.5 percentage of participants Interval 83.0 to 94.1
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	98.5 percentage of participants Interval 94.6 to 99.8	98.5 percentage of participants Interval 94.6 to 99.8
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	95.5 percentage of participants Interval 90.4 to 98.3	97.7 percentage of participants Interval 93.5 to 99.5
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	99.2 percentage of participants Interval 95.8 to 100.0	98.5 percentage of participants Interval 94.6 to 99.8
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	93.0 percentage of participants Interval 87.1 to 96.7	95.3 percentage of participants Interval 90.2 to 98.3
Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	86.2 percentage of participants Interval 79.0 to 91.6	92.3 percentage of participants Interval 86.3 to 96.2

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 1	89.1 percentage of participants Interval 82.5 to 93.9	94.0 percentage of participants Interval 88.6 to 97.4
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 3	87.9 percentage of participants Interval 81.1 to 92.9	91.8 percentage of participants Interval 85.8 to 95.8
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 4	93.5 percentage of participants Interval 87.6 to 97.2	96.9 percentage of participants Interval 92.3 to 99.1
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 5	85.8 percentage of participants Interval 78.5 to 91.4	91.3 percentage of participants Interval 85.0 to 95.6
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6A	97.7 percentage of participants Interval 93.5 to 99.5	99.2 percentage of participants Interval 95.9 to 100.0
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6B	97.7 percentage of participants Interval 93.4 to 99.5	99.3 percentage of participants Interval 95.9 to 100.0
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 7F	93.9 percentage of participants Interval 88.4 to 97.3	99.2 percentage of participants Interval 95.7 to 100.0
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 9V	88.6 percentage of participants Interval 82.0 to 93.5	89.5 percentage of participants Interval 83.0 to 94.1
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 14	98.5 percentage of participants Interval 94.6 to 99.8	98.5 percentage of participants Interval 94.6 to 99.8
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 18C	95.5 percentage of participants Interval 90.4 to 98.3	97.7 percentage of participants Interval 93.5 to 99.5
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19A	99.2 percentage of participants Interval 95.8 to 100.0	98.5 percentage of participants Interval 94.6 to 99.8
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19F	93.0 percentage of participants Interval 87.1 to 96.7	95.3 percentage of participants Interval 90.2 to 98.3
Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 23F	86.2 percentage of participants Interval 79.0 to 91.6	92.3 percentage of participants Interval 86.3 to 96.2

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=263 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	89.7 percentage of participants Interval 85.4 to 93.1	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	84.4 percentage of participants Interval 79.5 to 88.6	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	84.9 percentage of participants Interval 79.2 to 89.5	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	87.1 percentage of participants Interval 82.2 to 91.1	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	84.5 percentage of participants Interval 79.5 to 88.8	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	68.4 percentage of participants Interval 62.0 to 74.2	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	86.1 percentage of participants Interval 81.1 to 90.2	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	61.3 percentage of participants Interval 54.8 to 67.6	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	67.2 percentage of participants Interval 61.0 to 73.0	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	85.6 percentage of participants Interval 80.7 to 89.7	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	92.3 percentage of participants Interval 88.3 to 95.3	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	88.0 percentage of participants Interval 83.3 to 91.8	—
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	81.3 percentage of participants Interval 75.9 to 86.0	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	86.0 percentage of participants Interval 78.8 to 91.5	93.2 percentage of participants Interval 87.5 to 96.9
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	81.7 percentage of participants Interval 74.0 to 87.9	87.1 percentage of participants Interval 80.2 to 92.3
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	79.2 percentage of participants Interval 70.0 to 86.6	90.4 percentage of participants Interval 83.0 to 95.3
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	84.7 percentage of participants Interval 77.0 to 90.7	89.4 percentage of participants Interval 82.6 to 94.3
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	82.0 percentage of participants Interval 74.3 to 88.3	87.1 percentage of participants Interval 79.9 to 92.4
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	61.7 percentage of participants Interval 52.2 to 70.6	74.6 percentage of participants Interval 65.9 to 82.0
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	82.5 percentage of participants Interval 74.8 to 88.7	89.8 percentage of participants Interval 82.9 to 94.6
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	52.5 percentage of participants Interval 43.1 to 61.8	70.0 percentage of participants Interval 61.0 to 78.0
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	62.4 percentage of participants Interval 53.3 to 70.9	72.0 percentage of participants Interval 63.3 to 79.7
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	80.3 percentage of participants Interval 72.3 to 86.8	90.8 percentage of participants Interval 84.4 to 95.1
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	92.7 percentage of participants Interval 86.7 to 96.6	91.9 percentage of participants Interval 85.7 to 96.1
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	86.1 percentage of participants Interval 78.6 to 91.7	89.8 percentage of participants Interval 83.3 to 94.5
Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	80.0 percentage of participants Interval 71.7 to 86.7	82.5 percentage of participants Interval 74.8 to 88.7

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 1	86.0 percentage of participants Interval 78.8 to 91.5	93.2 percentage of participants Interval 87.5 to 96.9
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 3	81.7 percentage of participants Interval 74.0 to 87.9	87.1 percentage of participants Interval 80.2 to 92.3
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 4	79.2 percentage of participants Interval 70.0 to 86.6	90.4 percentage of participants Interval 83.0 to 95.3
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 5	84.7 percentage of participants Interval 77.0 to 90.7	89.4 percentage of participants Interval 82.6 to 94.3
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6A	82.0 percentage of participants Interval 74.3 to 88.3	87.1 percentage of participants Interval 79.9 to 92.4
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6B	61.7 percentage of participants Interval 52.2 to 70.6	74.6 percentage of participants Interval 65.9 to 82.0
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 7F	82.5 percentage of participants Interval 74.8 to 88.7	89.8 percentage of participants Interval 82.9 to 94.6
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 9V	52.5 percentage of participants Interval 43.1 to 61.8	70.0 percentage of participants Interval 61.0 to 78.0
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 14	62.4 percentage of participants Interval 53.3 to 70.9	72.0 percentage of participants Interval 63.3 to 79.7
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 18C	80.3 percentage of participants Interval 72.3 to 86.8	90.8 percentage of participants Interval 84.4 to 95.1
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19A	92.7 percentage of participants Interval 86.7 to 96.6	91.9 percentage of participants Interval 85.7 to 96.1
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19F	86.1 percentage of participants Interval 78.6 to 91.7	89.8 percentage of participants Interval 83.3 to 94.5
Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 23F	80.0 percentage of participants Interval 71.7 to 86.7	82.5 percentage of participants Interval 74.8 to 88.7

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=263 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	88.9 percentage of participants Interval 84.5 to 92.5	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	76.0 percentage of participants Interval 70.4 to 81.1	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	74.6 percentage of participants Interval 68.1 to 80.4	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	85.1 percentage of participants Interval 79.9 to 89.3	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	75.4 percentage of participants Interval 69.6 to 80.6	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	57.0 percentage of participants Interval 50.4 to 63.4	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	81.6 percentage of participants Interval 76.1 to 86.2	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	50.0 percentage of participants Interval 43.5 to 56.5	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	56.0 percentage of participants Interval 49.6 to 62.2	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	77.0 percentage of participants Interval 71.4 to 82.0	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	85.9 percentage of participants Interval 80.9 to 90.0	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	78.8 percentage of participants Interval 73.2 to 83.7	—
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	75.6 percentage of participants Interval 69.7 to 80.8	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	71.7 percentage of participants Interval 62.7 to 79.5	79.4 percentage of participants Interval 71.2 to 86.1
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	86.0 percentage of participants Interval 78.8 to 91.5	91.7 percentage of participants Interval 85.7 to 95.8
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	73.3 percentage of participants Interval 64.8 to 80.6	78.8 percentage of participants Interval 70.8 to 85.4
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	65.3 percentage of participants Interval 55.2 to 74.5	83.7 percentage of participants Interval 75.1 to 90.2
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	83.9 percentage of participants Interval 76.0 to 90.0	86.2 percentage of participants Interval 78.8 to 91.7
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	69.5 percentage of participants Interval 60.8 to 77.4	81.5 percentage of participants Interval 73.5 to 87.9
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	51.3 percentage of participants Interval 41.8 to 60.7	62.3 percentage of participants Interval 53.1 to 70.9
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	77.0 percentage of participants Interval 68.6 to 84.0	86.4 percentage of participants Interval 78.9 to 92.0
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	36.4 percentage of participants Interval 27.8 to 45.8	63.3 percentage of participants Interval 54.1 to 71.9
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	52.8 percentage of participants Interval 43.7 to 61.8	59.2 percentage of participants Interval 50.1 to 67.9
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	70.9 percentage of participants Interval 62.1 to 78.6	83.1 percentage of participants Interval 75.5 to 89.1
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	85.5 percentage of participants Interval 78.0 to 91.2	86.3 percentage of participants Interval 79.0 to 91.8
Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	73.0 percentage of participants Interval 64.2 to 80.6	84.4 percentage of participants Interval 76.9 to 90.2

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=131 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=133 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 18C	70.9 percentage of participants Interval 62.1 to 78.6	83.1 percentage of participants Interval 75.5 to 89.1
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 1	86.0 percentage of participants Interval 78.8 to 91.5	91.7 percentage of participants Interval 85.7 to 95.8
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 3	73.3 percentage of participants Interval 64.8 to 80.6	78.8 percentage of participants Interval 70.8 to 85.4
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 4	65.3 percentage of participants Interval 55.2 to 74.5	83.7 percentage of participants Interval 75.1 to 90.2
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 5	83.9 percentage of participants Interval 76.0 to 90.0	86.2 percentage of participants Interval 78.8 to 91.7
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6A	69.5 percentage of participants Interval 60.8 to 77.4	81.5 percentage of participants Interval 73.5 to 87.9
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6B	51.3 percentage of participants Interval 41.8 to 60.7	62.3 percentage of participants Interval 53.1 to 70.9
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 7F	77.0 percentage of participants Interval 68.6 to 84.0	86.4 percentage of participants Interval 78.9 to 92.0
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 9V	36.4 percentage of participants Interval 27.8 to 45.8	63.3 percentage of participants Interval 54.1 to 71.9
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 14	52.8 percentage of participants Interval 43.7 to 61.8	59.2 percentage of participants Interval 50.1 to 67.9
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19A	85.5 percentage of participants Interval 78.0 to 91.2	86.3 percentage of participants Interval 79.0 to 91.8
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19F	73.0 percentage of participants Interval 64.2 to 80.6	84.4 percentage of participants Interval 76.9 to 90.2
Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 23F	71.7 percentage of participants Interval 62.7 to 79.5	79.4 percentage of participants Interval 71.2 to 86.1

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.

Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=268 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	6.05 mcg/mL Interval 5.05 to 7.24	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	1.53 mcg/mL Interval 1.36 to 1.72	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	4.57 mcg/mL Interval 3.87 to 5.39	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	8.34 mcg/mL Interval 7.28 to 9.56	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	7.93 mcg/mL Interval 6.79 to 9.25	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	8.31 mcg/mL Interval 7.08 to 9.75	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	10.36 mcg/mL Interval 9.01 to 11.91	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	9.62 mcg/mL Interval 8.29 to 11.16	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	19.23 mcg/mL Interval 16.47 to 22.44	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	13.90 mcg/mL Interval 12.1 to 15.96	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	19.13 mcg/mL Interval 16.54 to 22.13	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	7.77 mcg/mL Interval 6.4 to 9.43	—
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	12.23 mcg/mL Interval 10.34 to 14.46	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	4.65 mcg/mL Interval 3.65 to 5.91	7.95 mcg/mL Interval 6.11 to 10.35
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	1.38 mcg/mL Interval 1.17 to 1.62	1.69 mcg/mL Interval 1.43 to 2.0
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	3.63 mcg/mL Interval 2.88 to 4.59	5.78 mcg/mL Interval 4.58 to 7.28
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	6.74 mcg/mL Interval 5.62 to 8.09	10.32 mcg/mL Interval 8.46 to 12.6
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	6.72 mcg/mL Interval 5.48 to 8.24	9.37 mcg/mL Interval 7.44 to 11.8
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	6.71 mcg/mL Interval 5.42 to 8.32	10.28 mcg/mL Interval 8.12 to 13.0
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	8.90 mcg/mL Interval 7.34 to 10.8	12.10 mcg/mL Interval 9.9 to 14.8
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	6.55 mcg/mL Interval 5.32 to 8.05	14.22 mcg/mL Interval 11.72 to 17.25
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	16.73 mcg/mL Interval 13.59 to 20.59	22.12 mcg/mL Interval 17.59 to 27.83
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	10.47 mcg/mL Interval 8.62 to 12.7	18.53 mcg/mL Interval 15.35 to 22.37
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	13.51 mcg/mL Interval 11.16 to 16.36	27.09 mcg/mL Interval 22.07 to 33.25
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	4.99 mcg/mL Interval 3.92 to 6.37	11.92 mcg/mL Interval 8.98 to 15.82
Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	9.38 mcg/mL Interval 7.35 to 11.98	15.93 mcg/mL Interval 12.75 to 19.91

SECONDARY outcome

Timeframe: 1 month after vaccination

Population: Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 1	4.65 mcg/mL Interval 3.65 to 5.91	7.69 mcg/mL Interval 5.94 to 9.96
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 3	1.35 mcg/mL Interval 1.15 to 1.58	1.69 mcg/mL Interval 1.43 to 2.0
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 4	3.53 mcg/mL Interval 2.8 to 4.45	5.35 mcg/mL Interval 4.25 to 6.75
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 5	6.74 mcg/mL Interval 5.62 to 8.09	10.32 mcg/mL Interval 8.46 to 12.6
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6A	6.72 mcg/mL Interval 5.48 to 8.24	9.45 mcg/mL Interval 7.51 to 11.89
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 6B	6.71 mcg/mL Interval 5.42 to 8.32	10.28 mcg/mL Interval 8.12 to 13.0
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 7F	8.90 mcg/mL Interval 7.34 to 10.8	12.09 mcg/mL Interval 9.92 to 14.73
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 9V	6.55 mcg/mL Interval 5.32 to 8.05	14.22 mcg/mL Interval 11.72 to 17.25
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 14	16.73 mcg/mL Interval 13.59 to 20.59	22.13 mcg/mL Interval 17.63 to 27.8
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 18C	10.47 mcg/mL Interval 8.62 to 12.7	18.48 mcg/mL Interval 15.32 to 22.28
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19A	13.51 mcg/mL Interval 11.16 to 16.36	27.09 mcg/mL Interval 22.07 to 33.25
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 19F	4.69 mcg/mL Interval 3.72 to 5.91	11.21 mcg/mL Interval 8.51 to 14.77
Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group Serotype 23F	9.38 mcg/mL Interval 7.35 to 11.98	15.93 mcg/mL Interval 12.75 to 19.91

SECONDARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=268 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 1	11.38 fold rise Interval 9.65 to 13.43	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 3	2.89 fold rise Interval 2.6 to 3.22	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 4	15.89 fold rise Interval 13.45 to 18.77	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 5	4.15 fold rise Interval 3.64 to 4.74	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6A	4.23 fold rise Interval 3.69 to 4.84	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 6B	4.32 fold rise Interval 3.76 to 4.96	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 7F	11.59 fold rise Interval 9.96 to 13.49	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 9V	8.56 fold rise Interval 7.43 to 9.87	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 14	6.79 fold rise Interval 5.78 to 7.98	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 18C	12.94 fold rise Interval 11.01 to 15.21	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19A	7.36 fold rise Interval 6.39 to 8.48	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 19F	6.03 fold rise Interval 5.1 to 7.14	—
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population Serotype 23F	7.80 fold rise Interval 6.7 to 9.07	—

SECONDARY outcome

Timeframe: 1 month after vaccination

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=134 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 1	8.86 fold rise Interval 7.08 to 11.09	14.77 fold rise Interval 11.65 to 18.72
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 3	2.40 fold rise Interval 2.07 to 2.79	3.47 fold rise Interval 2.98 to 4.05
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 4	11.33 fold rise Interval 9.06 to 14.19	22.44 fold rise Interval 17.75 to 28.38
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 5	3.23 fold rise Interval 2.7 to 3.85	5.34 fold rise Interval 4.42 to 6.46
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6A	3.32 fold rise Interval 2.8 to 3.94	5.39 fold rise Interval 4.38 to 6.64
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 6B	3.26 fold rise Interval 2.72 to 3.92	5.71 fold rise Interval 4.68 to 6.97
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 7F	9.10 fold rise Interval 7.39 to 11.22	14.88 fold rise Interval 12.0 to 18.45
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 9V	5.76 fold rise Interval 4.77 to 6.95	12.80 fold rise Interval 10.56 to 15.51
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 14	5.93 fold rise Interval 4.78 to 7.35	7.80 fold rise Interval 6.13 to 9.91
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 18C	9.92 fold rise Interval 7.99 to 12.31	16.96 fold rise Interval 13.42 to 21.43
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19A	5.12 fold rise Interval 4.3 to 6.1	10.57 fold rise Interval 8.6 to 12.99
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 19F	3.80 fold rise Interval 3.07 to 4.71	9.43 fold rise Interval 7.45 to 11.94
Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Serotype 23F	6.26 fold rise Interval 5.02 to 7.8	9.71 fold rise Interval 7.91 to 11.91

SECONDARY outcome

Timeframe: Day 1 through 14

Population: Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.

Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters \[cm\] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (\> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=238 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Redness: any	14.4 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Redness: mild	8.7 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Redness: moderate	9.3 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Redness: severe	0.5 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Swelling: any	11.5 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Swelling: mild	7.2 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Swelling: moderate	5.8 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Swelling: severe	0.5 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Pain: any	48.3 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Pain: mild	46.1 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Pain: moderate	9.6 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Pain: severe	0.5 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Limitation of arm movement: any	53.2 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Limitation of arm movement: mild	52.2 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Limitation of arm movement: moderate	4.4 percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population Limitation of arm movement: severe	1.5 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 through 14

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=120 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=118 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Limitation of arm movement: any	53.0 percentage of participants	53.4 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Limitation of arm movement: mild	51.8 percentage of participants	52.5 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Redness: mild	7.1 percentage of participants	10.0 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Redness: moderate	1.0 percentage of participants	16.7 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Redness: severe	0.0 percentage of participants	0.9 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Swelling: any	8.1 percentage of participants	14.7 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Swelling: mild	7.1 percentage of participants	7.3 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Swelling: moderate	2.0 percentage of participants	9.3 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Swelling: severe	0.0 percentage of participants	0.9 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Pain: any	52.2 percentage of participants	44.3 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Pain: mild	49.6 percentage of participants	42.6 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Pain: moderate	8.9 percentage of participants	10.3 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Pain: severe	1.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Limitation of arm movement: moderate	5.1 percentage of participants	3.7 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Limitation of arm movement: severe	2.1 percentage of participants	0.9 percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Redness: any	7.1 percentage of participants	20.9 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through 14

Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius \[C\]); Mild (≥37.5 but \<38.5 degrees C); Moderate (≥38.5 but \<39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (\>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=228 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Fatigue	31.2 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Rash	10.7 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Vomiting	2.0 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Decreased appetite	12.6 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population New muscle pain	31.8 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Any aggravated muscle pain	10.1 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population New joint pain	11.0 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Any aggravated joint pain	6.3 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Fever: any ≥37.5 degrees C	3.4 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Fever: mild ≥37.5 but <38.5 degrees C	2.9 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Fever: moderate ≥38.5 but <39 degrees C	0.5 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Headache	19.9 percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population Chills	12.7 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 through 14

Outcome measures

Outcome measures
Measure	13vPnC Overall Population (50 to 64 and ≥65 Years of Age) n=112 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.	13vPnC (≥65 Years of Age) n=116 Participants 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Fever any ≥37.5 degrees C	3.1 percentage of participants	3.7 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Fever: mild ≥37.5 but <38.5 degrees C	2.0 percentage of participants	3.7 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Fever: moderate ≥38.5 but <39 degrees C	1.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Fatigue	38.8 percentage of participants	24.1 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Decreased appetite	16.2 percentage of participants	9.3 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Any aggravated muscle pain	11.2 percentage of participants	9.1 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years New joint pain	10.0 percentage of participants	11.8 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Headache	26.0 percentage of participants	14.4 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Chills	14.9 percentage of participants	10.8 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Rash	8.2 percentage of participants	13.1 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Vomiting	3.1 percentage of participants	0.9 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years New muscle pain	34.3 percentage of participants	29.5 percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years Any aggravated joint pain	7.1 percentage of participants	5.5 percentage of participants

Adverse Events

13vPnC (50 to 64 Years of Age)

Serious events: 1 serious events

Other events: 120 other events

Deaths: 0 deaths

13vPnC (≥65 Years of Age)

Serious events: 1 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13vPnC (50 to 64 Years of Age) n=134 participants at risk 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age. For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods).	13vPnC (≥65 Years of Age) n=136 participants at risk 13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age. For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods).
Cardiac disorders Cardiac failure congestive	0.00% 0/134 • Adverse events reported via the electronic-diary were collected within 14 days of vaccination; all other adverse events were documented from the signing of the informed consent form up to approximately one month after vaccination (up to Day 43) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.74% 1/136 • Adverse events reported via the electronic-diary were collected within 14 days of vaccination; all other adverse events were documented from the signing of the informed consent form up to approximately one month after vaccination (up to Day 43) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Subarachnoid haemorrhage	0.75% 1/134 • Adverse events reported via the electronic-diary were collected within 14 days of vaccination; all other adverse events were documented from the signing of the informed consent form up to approximately one month after vaccination (up to Day 43) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/136 • Adverse events reported via the electronic-diary were collected within 14 days of vaccination; all other adverse events were documented from the signing of the informed consent form up to approximately one month after vaccination (up to Day 43) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER