Trial Outcomes & Findings for A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013) (NCT NCT06177912)

Last Updated: 2026-03-11

Results Overview

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

882 participants

Primary outcome timeframe

Up to 5 days postvaccination

Results posted on

2026-03-11

Participant Flow

Children and adolescents between 2 and 18 years of age with an increased risk of pneumococcal disease were enrolled in this study.

Participant milestones

Participant milestones
Measure	V116 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Overall Study STARTED	531	351
Overall Study Vaccinated	528	348
Overall Study Safety Analysis Population	527	347
Overall Study COMPLETED	522	345
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	V116 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Overall Study Death	0	2
Overall Study Lost to Follow-up	2	0
Overall Study Randomized By Mistake Without Study Treatment	1	1
Overall Study Withdrawal By Parent/Guardian	5	3
Overall Study Randomized By Mistake With Study Treatment	1	0

Baseline Characteristics

A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V116 n=531 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.	PPSV23 n=351 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	Total n=882 Participants Total of all reporting groups
Age, Continuous	8.2 Years STANDARD_DEVIATION 4.1 • n=9 Participants	7.8 Years STANDARD_DEVIATION 3.8 • n=9 Participants	8.0 Years STANDARD_DEVIATION 4.0 • n=18 Participants
Sex: Female, Male Female	220 Participants n=9 Participants	142 Participants n=9 Participants	362 Participants n=18 Participants
Sex: Female, Male Male	311 Participants n=9 Participants	209 Participants n=9 Participants	520 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	233 Participants n=9 Participants	158 Participants n=9 Participants	391 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	298 Participants n=9 Participants	192 Participants n=9 Participants	490 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	48 Participants n=9 Participants	43 Participants n=9 Participants	91 Participants n=18 Participants
Race (NIH/OMB) Asian	48 Participants n=9 Participants	37 Participants n=9 Participants	85 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	31 Participants n=9 Participants	20 Participants n=9 Participants	51 Participants n=18 Participants
Race (NIH/OMB) White	322 Participants n=9 Participants	203 Participants n=9 Participants	525 Participants n=18 Participants
Race (NIH/OMB) More than one race	82 Participants n=9 Participants	48 Participants n=9 Participants	130 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants

PRIMARY outcome

Timeframe: Up to 5 days postvaccination

Population: The analysis population consisted of all participants who received study vaccination and had documented initial consent.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Injection site erythema	16.4 Percentage of Participants	24.3 Percentage of Participants
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Injection site pain	54.5 Percentage of Participants	67.7 Percentage of Participants
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Injection site swelling	18.2 Percentage of Participants	18.8 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 5 days post vaccination

Population: The analysis population consisted of all participants who received study vaccination and had documented initial consent.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia).

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Percentage of Participants With Solicited Systemic AEs Arthralgia	5.5 Percentage of Participants	4.4 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Fatigue	21.0 Percentage of Participants	20.1 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Malaise	9.2 Percentage of Participants	13.3 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Myalgia	5.2 Percentage of Participants	6.3 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Urticaria	1.7 Percentage of Participants	2.7 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Headache	15.3 Percentage of Participants	17.1 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Irritability	11.0 Percentage of Participants	11.6 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Pyrexia	5.8 Percentage of Participants	4.6 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Somnolence	9.2 Percentage of Participants	9.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 6 months

Population: The analysis population consisted of all participants who received study vaccination and had documented initial consent.

A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	0.6 Percentage of Participants	0.2 Percentage of Participants

PRIMARY outcome

Timeframe: 30 days postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype.

Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

Outcome measures

SECONDARY outcome

Timeframe: 30 days postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination IgG serology data for the respective serotype.

The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific IgGs and GMC ratios with 95% CIs were calculated using a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal OPA serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 3	7.6 Ratio Interval 6.4 to 9.0	7.9 Ratio Interval 6.8 to 9.1
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 7F	10.5 Ratio Interval 9.0 to 12.4	15.8 Ratio Interval 13.7 to 18.3
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 8	21.7 Ratio Interval 17.8 to 26.4	30.5 Ratio Interval 25.9 to 36.0
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 10A	6.0 Ratio Interval 4.7 to 7.5	15.4 Ratio Interval 12.5 to 19.0
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 11A	5.9 Ratio Interval 4.5 to 7.8	18.6 Ratio Interval 14.9 to 23.4
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 12F	149.3 Ratio Interval 122.1 to 182.6	452.7 Ratio Interval 378.6 to 541.4
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 17F	9.9 Ratio Interval 8.2 to 11.8	33.3 Ratio Interval 28.3 to 39.2
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 19A	7.2 Ratio Interval 6.1 to 8.7	6.6 Ratio Interval 5.6 to 7.7
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 20A	4.1 Ratio Interval 3.5 to 4.9	10.4 Ratio Interval 9.0 to 12.0
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 22F	8.4 Ratio Interval 6.8 to 10.3	22.2 Ratio Interval 18.3 to 26.8
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 33F	10.0 Ratio Interval 8.6 to 11.6	18.2 Ratio Interval 16.1 to 20.5
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 6A	7.1 Ratio Interval 5.6 to 9.0	22.1 Ratio Interval 17.8 to 27.4
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 15A	2.0 Ratio Interval 1.8 to 2.3	26.6 Ratio Interval 23.3 to 30.4
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 16F	1.5 Ratio Interval 1.3 to 1.6	7.6 Ratio Interval 6.7 to 8.6
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 23A	2.2 Ratio Interval 1.8 to 2.7	14.2 Ratio Interval 11.7 to 17.2
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 23B	6.2 Ratio Interval 4.5 to 8.4	92.9 Ratio Interval 70.3 to 122.8
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 24F	1.1 Ratio Interval 0.9 to 1.3	4.4 Ratio Interval 3.8 to 5.1
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 31	1.6 Ratio Interval 1.3 to 1.8	28.8 Ratio Interval 24.1 to 34.4
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 35B	1.3 Ratio Interval 1.2 to 1.4	6.0 Ratio Interval 5.3 to 6.8
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 9N	8.0 Ratio Interval 6.8 to 9.3	13.9 Ratio Interval 12.1 to 15.9
Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs Serotype 15C	13.4 Ratio Interval 10.2 to 17.7	124.5 Ratio Interval 95.0 to 163.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 3	66.1 Percentage of Participants Interval 60.1 to 71.6	64.6 Percentage of Participants Interval 59.8 to 69.3
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 7F	79.7 Percentage of Participants Interval 74.4 to 84.3	84.2 Percentage of Participants Interval 80.3 to 87.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 8	90.6 Percentage of Participants Interval 86.3 to 93.9	92.3 Percentage of Participants Interval 89.2 to 94.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 9N	71.7 Percentage of Participants Interval 65.9 to 77.0	82.8 Percentage of Participants Interval 78.8 to 86.3
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 10A	47.5 Percentage of Participants Interval 41.2 to 53.8	73.5 Percentage of Participants Interval 68.7 to 77.9
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 19A	64.0 Percentage of Participants Interval 58.0 to 69.7	57.8 Percentage of Participants Interval 52.9 to 62.7
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 33F	74.2 Percentage of Participants Interval 68.5 to 79.3	88.9 Percentage of Participants Interval 85.5 to 91.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 6A	55.7 Percentage of Participants Interval 49.2 to 62.0	76.3 Percentage of Participants Interval 71.7 to 80.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 23A	27.4 Percentage of Participants Interval 21.6 to 33.8	75.2 Percentage of Participants Interval 70.2 to 79.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 23B	42.7 Percentage of Participants Interval 36.4 to 49.2	78.2 Percentage of Participants Interval 73.8 to 82.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 11A	46.2 Percentage of Participants Interval 39.9 to 52.6	76.2 Percentage of Participants Interval 71.7 to 80.4
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 12F	96.0 Percentage of Participants Interval 93.0 to 98.0	96.7 Percentage of Participants Interval 94.5 to 98.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 17F	74.0 Percentage of Participants Interval 68.2 to 79.3	92.4 Percentage of Participants Interval 89.3 to 94.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 20A	48.0 Percentage of Participants Interval 41.8 to 54.4	77.8 Percentage of Participants Interval 73.2 to 82.0
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 22F	65.3 Percentage of Participants Interval 59.2 to 71.0	84.1 Percentage of Participants Interval 80.1 to 87.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 15A	22.8 Percentage of Participants Interval 17.9 to 28.3	91.3 Percentage of Participants Interval 88.0 to 93.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 15C	68.9 Percentage of Participants Interval 62.6 to 74.7	90.7 Percentage of Participants Interval 87.2 to 93.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 16F	13.5 Percentage of Participants Interval 9.6 to 18.3	67.5 Percentage of Participants Interval 62.7 to 72.1
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 24F	7.9 Percentage of Participants Interval 4.7 to 12.4	47.6 Percentage of Participants Interval 42.3 to 52.9
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 31	13.6 Percentage of Participants Interval 9.6 to 18.5	89.9 Percentage of Participants Interval 86.4 to 92.7
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs Serotype 35B	7.8 Percentage of Participants Interval 4.8 to 11.8	60.7 Percentage of Participants Interval 55.7 to 65.6

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

The GMFR from baseline in serotype-specific IgG GMCs was determined using PnECL at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 23B	3.4 Ratio Interval 2.9 to 4.1	18.3 Ratio Interval 15.3 to 21.9
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 24F	1.1 Ratio Interval 1.0 to 1.2	12.6 Ratio Interval 10.8 to 14.7
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 35B	1.0 Ratio Interval 1.0 to 1.1	10.1 Ratio Interval 8.8 to 11.5
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 31	1.5 Ratio Interval 1.4 to 1.7	25.3 Ratio Interval 22.4 to 28.6
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 20A	7.1 Ratio Interval 6.1 to 8.3	11.4 Ratio Interval 10.1 to 12.9
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 22F	35.7 Ratio Interval 28.5 to 44.8	41.8 Ratio Interval 34.7 to 50.4
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 15C	7.4 Ratio Interval 6.2 to 9.0	42.4 Ratio Interval 36.8 to 48.9
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 16F	1.4 Ratio Interval 1.2 to 1.5	15.4 Ratio Interval 13.6 to 17.5
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 23A	4.1 Ratio Interval 3.4 to 4.8	28.8 Ratio Interval 24.8 to 33.5
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 3	6.6 Ratio Interval 5.5 to 7.9	5.8 Ratio Interval 5.0 to 6.6
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 7F	23.3 Ratio Interval 20.2 to 26.9	23.0 Ratio Interval 20.4 to 26.0
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 8	40.5 Ratio Interval 34.4 to 47.7	34.5 Ratio Interval 30.4 to 39.1
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 9N	31.5 Ratio Interval 26.4 to 37.7	22.5 Ratio Interval 19.5 to 26.0
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 10A	12.3 Ratio Interval 10.3 to 14.8	20.4 Ratio Interval 17.9 to 23.2
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 11A	7.5 Ratio Interval 6.2 to 8.9	13.7 Ratio Interval 11.7 to 16.0
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 12F	17.5 Ratio Interval 14.8 to 20.6	22.6 Ratio Interval 20.1 to 25.3
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 17F	16.7 Ratio Interval 14.2 to 19.7	41.6 Ratio Interval 36.6 to 47.4
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 19A	9.3 Ratio Interval 7.5 to 11.4	8.1 Ratio Interval 6.9 to 9.5
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 33F	26.3 Ratio Interval 22.1 to 31.2	19.9 Ratio Interval 17.7 to 22.3
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 6A	13.1 Ratio Interval 10.8 to 15.9	25.9 Ratio Interval 21.7 to 31.0
GMFR From Baseline in Serotype-specific IgG GMCs Serotype 15A	3.3 Ratio Interval 2.8 to 3.9	32.0 Ratio Interval 27.8 to 36.9

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Titer levels were determined by PnECL and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.

Outcome measures

Outcome measures
Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 3	62.2 Percentage of Participants Interval 55.6 to 68.5	59.3 Percentage of Participants Interval 54.1 to 64.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 7F	97.4 Percentage of Participants Interval 94.4 to 99.0	92.5 Percentage of Participants Interval 89.2 to 95.0
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 8	94.8 Percentage of Participants Interval 91.1 to 97.3	94.4 Percentage of Participants Interval 91.5 to 96.6
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 9N	92.2 Percentage of Participants Interval 87.9 to 95.3	88.0 Percentage of Participants Interval 84.2 to 91.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 10A	80.9 Percentage of Participants Interval 75.2 to 85.7	88.0 Percentage of Participants Interval 84.2 to 91.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 22F	87.0 Percentage of Participants Interval 81.9 to 91.0	85.5 Percentage of Participants Interval 81.4 to 89.0
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 23A	43.9 Percentage of Participants Interval 37.4 to 50.6	89.4 Percentage of Participants Interval 85.8 to 92.4
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 23B	39.6 Percentage of Participants Interval 33.2 to 46.2	76.0 Percentage of Participants Interval 71.3 to 80.4
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 35B	0.9 Percentage of Participants Interval 0.1 to 3.1	76.6 Percentage of Participants Interval 71.9 to 80.9
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 11A	63.9 Percentage of Participants Interval 57.3 to 70.1	77.2 Percentage of Participants Interval 72.5 to 81.4
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 12F	88.7 Percentage of Participants Interval 83.9 to 92.5	93.3 Percentage of Participants Interval 90.2 to 95.7
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 17F	87.4 Percentage of Participants Interval 82.4 to 91.4	95.5 Percentage of Participants Interval 92.8 to 97.4
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 19A	67.0 Percentage of Participants Interval 60.5 to 73.0	63.8 Percentage of Participants Interval 58.6 to 68.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 20A	66.1 Percentage of Participants Interval 59.6 to 72.2	78.8 Percentage of Participants Interval 74.2 to 82.9
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 33F	91.3 Percentage of Participants Interval 86.9 to 94.6	91.1 Percentage of Participants Interval 87.6 to 93.8
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 6A	76.5 Percentage of Participants Interval 70.5 to 81.8	83.8 Percentage of Participants Interval 79.6 to 87.5
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 15A	37.4 Percentage of Participants Interval 31.1 to 44.0	92.8 Percentage of Participants Interval 89.6 to 95.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 15C	63.9 Percentage of Participants Interval 57.3 to 70.1	94.2 Percentage of Participants Interval 91.2 to 96.3
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 16F	7.0 Percentage of Participants Interval 4.0 to 11.1	85.8 Percentage of Participants Interval 81.7 to 89.2
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 24F	3.0 Percentage of Participants Interval 1.2 to 6.2	75.2 Percentage of Participants Interval 70.4 to 79.6
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs Serotype 31	7.4 Percentage of Participants Interval 4.4 to 11.6	93.3 Percentage of Participants Interval 90.2 to 95.7

Adverse Events

V116

Serious events: 29 serious events

Other events: 408 other events

Deaths: 0 deaths

PPSV23

Serious events: 25 serious events

Other events: 237 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V116 n=527 participants at risk Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.	PPSV23 n=347 participants at risk Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
General disorders Fatigue	20.3% 107/527 • Number of events 109 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	21.0% 73/347 • Number of events 74 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
General disorders Injection site erythema	24.7% 130/527 • Number of events 130 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	16.4% 57/347 • Number of events 58 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
General disorders Injection site pain	67.7% 357/527 • Number of events 357 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	54.5% 189/347 • Number of events 189 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
General disorders Injection site swelling	18.8% 99/527 • Number of events 99 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	18.2% 63/347 • Number of events 64 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
General disorders Malaise	13.3% 70/527 • Number of events 70 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	9.5% 33/347 • Number of events 33 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
General disorders Pyrexia	6.3% 33/527 • Number of events 35 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	7.2% 25/347 • Number of events 25 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Infections and infestations Nasopharyngitis	5.1% 27/527 • Number of events 27 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	3.5% 12/347 • Number of events 13 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 24/527 • Number of events 24 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	5.8% 20/347 • Number of events 20 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 34/527 • Number of events 34 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	5.2% 18/347 • Number of events 18 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Nervous system disorders Headache	17.8% 94/527 • Number of events 100 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	15.3% 53/347 • Number of events 57 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Nervous system disorders Somnolence	9.5% 50/527 • Number of events 50 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	9.2% 32/347 • Number of events 32 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
Psychiatric disorders Irritability	11.6% 61/527 • Number of events 61 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.	11.0% 38/347 • Number of events 38 • Up to approximately 6 months The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 3	517.0 Titers Per protocol, no within-group MOD were planned or calculated.	526.6 Titers Per protocol, no within-group method of dispersion (MOD) were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 9N	18587.8 Titers Per protocol, no within-group MOD were planned or calculated.	35556.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 11A	3129.8 Titers Per protocol, no within-group MOD were planned or calculated.	10396.3 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 12F	4820.1 Titers Per protocol, no within-group MOD were planned or calculated.	14752.0 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 17F	11267.4 Titers Per protocol, no within-group MOD were planned or calculated.	40011.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 19A	9797.6 Titers Per protocol, no within-group MOD were planned or calculated.	9009.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 20A	14787.0 Titers Per protocol, no within-group MOD were planned or calculated.	37532.2 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 22F	7770.3 Titers Per protocol, no within-group MOD were planned or calculated.	20162.7 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 33F	40609.0 Titers Per protocol, no within-group MOD were planned or calculated.	73201.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 15A	5332.2 Titers Per protocol, no within-group MOD were planned or calculated.	69527.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 23B	370.5 Titers Per protocol, no within-group MOD were planned or calculated.	5988.2 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 24F	2771.8 Titers Per protocol, no within-group MOD were planned or calculated.	11102.2 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 31	2563.0 Titers Per protocol, no within-group MOD were planned or calculated.	46163.7 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 35B	7812.5 Titers Per protocol, no within-group MOD were planned or calculated.	40102.8 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 7F	14207.2 Titers Per protocol, no within-group MOD were planned or calculated.	20618.1 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 8	8966.9 Titers Per protocol, no within-group MOD were planned or calculated.	12294.5 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 10A	5363.8 Titers Per protocol, no within-group MOD were planned or calculated.	13719.7 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 6A	5653.8 Titers Per protocol, no within-group MOD were planned or calculated.	16910.9 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 15C	4398.4 Titers Per protocol, no within-group MOD were planned or calculated.	34539.1 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 16F	5449.7 Titers Per protocol, no within-group MOD were planned or calculated.	31544.9 Titers Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses Serotype 23A	4882.0 Titers Per protocol, no within-group MOD were planned or calculated.	28591.7 Titers Per protocol, no within-group MOD were planned or calculated.

Measure	PPSV23 n=347 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	V116 n=527 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 3	1.88 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	1.56 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 7F	7.37 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	7.33 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 8	17.86 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	13.68 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 9N	9.41 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	7.11 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 10A	4.69 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	8.47 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 11A	4.32 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	7.47 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 12F	1.38 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	1.78 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 17F	6.13 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	14.75 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 19A	15.97 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	13.50 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 20A	5.75 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	9.09 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 22F	10.23 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	14.20 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 33F	9.34 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	6.75 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 15C	2.55 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	13.54 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 16F	0.18 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	2.35 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 23A	1.05 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	7.17 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 35B	0.89 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	8.96 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 6A	6.25 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	11.98 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 15A	1.24 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	12.00 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 23B	1.29 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	6.47 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 24F	0.22 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	2.39 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination Serotype 31	0.27 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.	4.67 μg/mL NA = Per protocol, no within-group MOD were planned or calculated.