Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4) (NCT NCT05464420)

Last Updated: 2024-09-24

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. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2162 participants

Primary outcome timeframe

Up to 5 days

Results posted on

2024-09-24

Participant Flow

Healthy pneumococcal vaccine-naïve adults between 18 and 49 years of age were enrolled in this study.

Participant milestones

Participant milestones
Measure	V116 Lot 1 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Overall Study STARTED	541	540	541	540
Overall Study Vaccinated	539	538	540	540
Overall Study Safety Analysis Population	539	536	541	541
Overall Study COMPLETED	521	520	525	526
Overall Study NOT COMPLETED	20	20	16	14

Reasons for withdrawal

Reasons for withdrawal
Measure	V116 Lot 1 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	16	11	11	11
Overall Study Randomized in Error Without Study Treatment	0	1	0	0
Overall Study Withdrawal by Subject	4	8	3	1
Overall Study Protocol Violation	0	0	1	1
Overall Study Unable to Adhere to Study Schedule	0	0	1	0

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V116 Lot 1 n=541 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 n=540 Participants Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.	Total n=2162 Participants Total of all reporting groups
Age, Continuous	34.8 Years STANDARD_DEVIATION 9.3 • n=5 Participants	34.8 Years STANDARD_DEVIATION 9.2 • n=7 Participants	34.3 Years STANDARD_DEVIATION 9.3 • n=5 Participants	34.4 Years STANDARD_DEVIATION 9.2 • n=4 Participants	34.6 Years STANDARD_DEVIATION 9.3 • n=21 Participants
Sex: Female, Male Female	305 Participants n=5 Participants	321 Participants n=7 Participants	311 Participants n=5 Participants	310 Participants n=4 Participants	1247 Participants n=21 Participants
Sex: Female, Male Male	236 Participants n=5 Participants	219 Participants n=7 Participants	230 Participants n=5 Participants	230 Participants n=4 Participants	915 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	98 Participants n=5 Participants	104 Participants n=7 Participants	113 Participants n=5 Participants	107 Participants n=4 Participants	422 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	440 Participants n=5 Participants	434 Participants n=7 Participants	420 Participants n=5 Participants	430 Participants n=4 Participants	1724 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	35 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	43 Participants n=7 Participants	55 Participants n=5 Participants	48 Participants n=4 Participants	195 Participants n=21 Participants
Race (NIH/OMB) White	458 Participants n=5 Participants	458 Participants n=7 Participants	458 Participants n=5 Participants	453 Participants n=4 Participants	1827 Participants n=21 Participants
Race (NIH/OMB) More than one race	16 Participants n=5 Participants	24 Participants n=7 Participants	16 Participants n=5 Participants	26 Participants n=4 Participants	82 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 5 days

Population: Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 incorrectly received V116 Lot 3 and one participant randomized into the V116 Lot 2 group incorrectly received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm incorrectly received PPSV23.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=536 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots Injection site erythema	13.4 Percentage of Participants Interval 10.6 to 16.5	14.2 Percentage of Participants Interval 11.3 to 17.4	13.1 Percentage of Participants Interval 10.4 to 16.3	—
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots Injection site pain	72.9 Percentage of Participants Interval 68.9 to 76.6	72.9 Percentage of Participants Interval 69.0 to 76.7	73.9 Percentage of Participants Interval 70.0 to 77.6	—
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots Injection site swelling	12.4 Percentage of Participants Interval 9.8 to 15.5	15.3 Percentage of Participants Interval 12.4 to 18.6	11.8 Percentage of Participants Interval 9.2 to 14.9	—

PRIMARY outcome

Timeframe: Up to 5 days

Population: All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.

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. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=1616 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 Injection site erythema	13.6 Percentage of Participants	7.6 Percentage of Participants	—	—
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 Injection site pain	73.3 Percentage of Participants	60.6 Percentage of Participants	—	—
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 Injection site swelling	13.2 Percentage of Participants	7.6 Percentage of Participants	—	—

PRIMARY outcome

Timeframe: Up to 5 days

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 systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=536 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots Fatigue	38.0 Percentage of Participants Interval 33.9 to 42.3	34.0 Percentage of Participants Interval 30.0 to 38.1	34.4 Percentage of Participants Interval 30.4 to 38.6	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots Headache	28.0 Percentage of Participants Interval 24.3 to 32.0	26.1 Percentage of Participants Interval 22.4 to 30.1	27.5 Percentage of Participants Interval 23.8 to 31.5	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots Myalgia	18.2 Percentage of Participants Interval 15.0 to 21.7	13.6 Percentage of Participants Interval 10.8 to 16.8	17.2 Percentage of Participants Interval 14.1 to 20.6	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots Pyrexia	3.2 Percentage of Participants Interval 1.8 to 5.0	2.2 Percentage of Participants Interval 1.2 to 3.9	3.5 Percentage of Participants Interval 2.1 to 5.4	—

PRIMARY outcome

Timeframe: Up to 5 days

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 systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=1616 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 Fatigue	35.5 Percentage of Participants	34.0 Percentage of Participants	—	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 Headache	27.2 Percentage of Participants	21.4 Percentage of Participants	—	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 Myalgia	16.3 Percentage of Participants	8.7 Percentage of Participants	—	—
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 Pyrexia	3.0 Percentage of Participants	2.2 Percentage of Participants	—	—

PRIMARY outcome

Timeframe: Up to 194 days

An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=536 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots	0.0 Percentage of Participants Interval 0.0 to 0.7	0.0 Percentage of Participants Interval 0.0 to 0.7	0.0 Percentage of Participants Interval 0.0 to 0.7	—

PRIMARY outcome

Timeframe: Up to 194 days

An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=1616 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=541 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23	0.0 Percentage of Participants	0.0 Percentage of Participants	—	—

PRIMARY outcome

Timeframe: Day 30

Population: Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.

Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex 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. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

SECONDARY outcome

Timeframe: Day 30

Population: All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.

Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.

Outcome measures

SECONDARY outcome

Timeframe: Day 30

Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

SECONDARY outcome

Timeframe: Day 30

Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30

Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	8.2 Ratio Interval 7.2 to 9.4	8.1 Ratio Interval 7.2 to 9.1	8.2 Ratio Interval 7.3 to 9.3	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	20.0 Ratio Interval 16.1 to 24.7	15.4 Ratio Interval 12.6 to 18.8	18.1 Ratio Interval 14.9 to 22.0	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	30.9 Ratio Interval 24.8 to 38.4	27.7 Ratio Interval 22.6 to 34.1	30.0 Ratio Interval 24.5 to 36.7	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	46.8 Ratio Interval 38.5 to 56.8	37.8 Ratio Interval 31.1 to 45.9	35.8 Ratio Interval 29.7 to 43.2	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	17.6 Ratio Interval 14.6 to 21.2	14.2 Ratio Interval 11.8 to 17.0	14.8 Ratio Interval 12.4 to 17.6	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	17.6 Ratio Interval 14.7 to 21.1	16.2 Ratio Interval 13.6 to 19.2	15.4 Ratio Interval 12.9 to 18.5	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	10.1 Ratio Interval 8.8 to 11.7	10.4 Ratio Interval 9.0 to 12.0	10.5 Ratio Interval 9.0 to 12.2	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	14.1 Ratio Interval 11.8 to 16.7	15.2 Ratio Interval 12.8 to 18.0	15.9 Ratio Interval 13.3 to 18.9	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	11.5 Ratio Interval 9.5 to 14.0	11.3 Ratio Interval 9.3 to 13.8	9.3 Ratio Interval 7.8 to 11.1	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	173.7 Ratio Interval 144.8 to 208.5	152.0 Ratio Interval 127.5 to 181.2	194.1 Ratio Interval 162.5 to 231.7	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	9.3 Ratio Interval 7.8 to 11.2	8.8 Ratio Interval 7.5 to 10.5	9.5 Ratio Interval 7.9 to 11.3	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	86.0 Ratio Interval 68.7 to 107.8	78.8 Ratio Interval 64.0 to 97.0	63.8 Ratio Interval 51.2 to 79.5	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	7.1 Ratio Interval 6.2 to 8.2	7.6 Ratio Interval 6.6 to 8.8	6.9 Ratio Interval 6.2 to 7.8	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	17.8 Ratio Interval 15.3 to 20.9	18.5 Ratio Interval 15.8 to 21.6	16.9 Ratio Interval 14.4 to 19.8	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	8.9 Ratio Interval 7.7 to 10.3	8.5 Ratio Interval 7.4 to 9.9	8.9 Ratio Interval 7.8 to 10.3	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	10.6 Ratio Interval 9.1 to 12.3	11.7 Ratio Interval 10.2 to 13.4	9.5 Ratio Interval 8.3 to 10.8	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	104.1 Ratio Interval 85.2 to 127.2	91.0 Ratio Interval 74.5 to 111.2	106.0 Ratio Interval 87.2 to 128.8	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	27.0 Ratio Interval 22.2 to 32.9	24.0 Ratio Interval 19.6 to 29.2	25.4 Ratio Interval 20.8 to 31.0	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	25.1 Ratio Interval 20.3 to 31.2	25.7 Ratio Interval 20.9 to 31.6	21.2 Ratio Interval 17.2 to 26.1	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	13.1 Ratio Interval 11.2 to 15.2	12.5 Ratio Interval 10.7 to 14.5	12.3 Ratio Interval 10.6 to 14.2	—
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	4.6 Ratio Interval 4.1 to 5.2	5.0 Ratio Interval 4.4 to 5.7	4.7 Ratio Interval 4.1 to 5.3	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30

Serotype-specific OPA titer were determined using MOPA. The percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	87.2 Percentage of Participants Interval 83.3 to 90.4	86.5 Percentage of Participants Interval 82.7 to 89.7	85.6 Percentage of Participants Interval 81.8 to 88.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	73.5 Percentage of Participants Interval 69.1 to 77.6	69.7 Percentage of Participants Interval 65.1 to 73.9	71.7 Percentage of Participants Interval 67.2 to 75.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	72.7 Percentage of Participants Interval 68.3 to 76.7	75.9 Percentage of Participants Interval 71.7 to 79.7	70.4 Percentage of Participants Interval 66.0 to 74.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	69.6 Percentage of Participants Interval 65.1 to 73.9	70.4 Percentage of Participants Interval 65.9 to 74.6	72.1 Percentage of Participants Interval 67.6 to 76.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	64.3 Percentage of Participants Interval 59.5 to 68.8	66.0 Percentage of Participants Interval 61.3 to 70.4	61.3 Percentage of Participants Interval 56.7 to 65.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	94.5 Percentage of Participants Interval 91.9 to 96.4	94.5 Percentage of Participants Interval 92.0 to 96.4	95.6 Percentage of Participants Interval 93.2 to 97.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	66.9 Percentage of Participants Interval 61.3 to 72.1	66.2 Percentage of Participants Interval 60.7 to 71.3	67.5 Percentage of Participants Interval 62.1 to 72.6	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	87.5 Percentage of Participants Interval 83.8 to 90.6	90.3 Percentage of Participants Interval 87.0 to 93.0	88.3 Percentage of Participants Interval 84.7 to 91.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	72.3 Percentage of Participants Interval 67.5 to 76.8	77.8 Percentage of Participants Interval 73.4 to 81.8	72.7 Percentage of Participants Interval 68.1 to 77.0	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	76.3 Percentage of Participants Interval 71.9 to 80.3	73.3 Percentage of Participants Interval 68.7 to 77.5	78.4 Percentage of Participants Interval 74.2 to 82.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	91.4 Percentage of Participants Interval 88.3 to 93.8	89.3 Percentage of Participants Interval 86.0 to 92.0	90.3 Percentage of Participants Interval 87.2 to 92.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	78.9 Percentage of Participants Interval 74.4 to 82.8	78.2 Percentage of Participants Interval 73.8 to 82.2	76.7 Percentage of Participants Interval 72.2 to 80.7	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	52.9 Percentage of Participants Interval 48.0 to 57.7	49.5 Percentage of Participants Interval 44.7 to 54.3	48.5 Percentage of Participants Interval 43.8 to 53.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	70.7 Percentage of Participants Interval 66.1 to 75.1	71.0 Percentage of Participants Interval 66.4 to 75.2	70.6 Percentage of Participants Interval 66.1 to 74.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	70.6 Percentage of Participants Interval 66.1 to 74.9	75.1 Percentage of Participants Interval 70.8 to 79.0	73.8 Percentage of Participants Interval 69.5 to 77.8	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	66.0 Percentage of Participants Interval 61.0 to 70.7	63.7 Percentage of Participants Interval 58.8 to 68.4	62.5 Percentage of Participants Interval 57.6 to 67.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	82.0 Percentage of Participants Interval 78.1 to 85.5	81.4 Percentage of Participants Interval 77.5 to 84.9	80.8 Percentage of Participants Interval 76.9 to 84.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	65.2 Percentage of Participants Interval 60.6 to 69.7	65.0 Percentage of Participants Interval 60.4 to 69.3	66.2 Percentage of Participants Interval 61.8 to 70.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	79.7 Percentage of Participants Interval 75.0 to 83.8	79.4 Percentage of Participants Interval 74.9 to 83.4	82.1 Percentage of Participants Interval 77.7 to 85.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	78.3 Percentage of Participants Interval 73.9 to 82.4	79.1 Percentage of Participants Interval 74.8 to 82.9	77.6 Percentage of Participants Interval 73.2 to 81.6	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	75.3 Percentage of Participants Interval 70.7 to 79.5	73.2 Percentage of Participants Interval 68.7 to 77.5	75.1 Percentage of Participants Interval 70.7 to 79.1	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30

Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	20.4 Ratio Interval 17.9 to 23.3	19.1 Ratio Interval 16.6 to 22.0	19.4 Ratio Interval 17.0 to 22.2	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	4.4 Ratio Interval 4.0 to 4.8	4.7 Ratio Interval 4.3 to 5.2	4.6 Ratio Interval 4.1 to 5.0	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	7.2 Ratio Interval 6.5 to 8.0	7.2 Ratio Interval 6.5 to 8.0	7.0 Ratio Interval 6.3 to 7.8	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	28.5 Ratio Interval 25.3 to 32.2	27.8 Ratio Interval 24.7 to 31.3	27.3 Ratio Interval 24.2 to 30.9	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	8.4 Ratio Interval 7.6 to 9.3	8.8 Ratio Interval 7.9 to 9.9	9.1 Ratio Interval 8.2 to 10.1	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	23.5 Ratio Interval 21.0 to 26.3	23.1 Ratio Interval 20.6 to 25.9	21.5 Ratio Interval 19.2 to 24.1	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	9.2 Ratio Interval 8.3 to 10.3	9.8 Ratio Interval 8.8 to 10.9	9.8 Ratio Interval 8.8 to 10.9	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	20.3 Ratio Interval 18.0 to 22.8	20.1 Ratio Interval 17.9 to 22.5	20.3 Ratio Interval 18.0 to 22.9	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	14.7 Ratio Interval 13.0 to 16.6	15.4 Ratio Interval 13.6 to 17.5	14.6 Ratio Interval 12.9 to 16.6	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	13.6 Ratio Interval 12.3 to 15.0	15.7 Ratio Interval 14.1 to 17.5	13.0 Ratio Interval 11.7 to 14.5	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	21.2 Ratio Interval 18.7 to 24.1	18.8 Ratio Interval 16.6 to 21.5	21.0 Ratio Interval 18.7 to 23.7	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	13.7 Ratio Interval 12.3 to 15.2	13.4 Ratio Interval 12.1 to 14.8	12.6 Ratio Interval 11.3 to 14.0	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	14.3 Ratio Interval 12.7 to 16.2	15.2 Ratio Interval 13.5 to 17.0	14.5 Ratio Interval 12.8 to 16.4	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	15.9 Ratio Interval 14.3 to 17.8	15.3 Ratio Interval 13.6 to 17.3	17.1 Ratio Interval 15.2 to 19.3	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	15.0 Ratio Interval 13.4 to 16.8	15.2 Ratio Interval 13.5 to 17.1	15.7 Ratio Interval 14.0 to 17.6	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	16.3 Ratio Interval 14.4 to 18.4	17.1 Ratio Interval 15.1 to 19.3	15.8 Ratio Interval 14.1 to 17.8	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	23.1 Ratio Interval 20.6 to 25.9	22.8 Ratio Interval 20.4 to 25.5	23.4 Ratio Interval 20.9 to 26.3	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	5.5 Ratio Interval 4.9 to 6.1	5.8 Ratio Interval 5.2 to 6.4	6.0 Ratio Interval 5.4 to 6.7	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	13.9 Ratio Interval 12.2 to 15.7	14.0 Ratio Interval 12.2 to 16.0	15.0 Ratio Interval 13.2 to 17.1	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	8.8 Ratio Interval 7.9 to 9.8	9.1 Ratio Interval 8.2 to 10.1	9.1 Ratio Interval 8.2 to 10.0	—
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	7.3 Ratio Interval 6.5 to 8.1	7.3 Ratio Interval 6.6 to 8.1	7.2 Ratio Interval 6.5 to 8.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30

Serotype-specific IgG concentrations were determined using PnECL. The percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	51.8 Percentage of Participants Interval 47.3 to 56.3	54.4 Percentage of Participants Interval 49.9 to 58.8	52.0 Percentage of Participants Interval 47.5 to 56.4	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	87.8 Percentage of Participants Interval 84.6 to 90.6	85.3 Percentage of Participants Interval 81.9 to 88.2	89.3 Percentage of Participants Interval 86.3 to 91.9	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	83.2 Percentage of Participants Interval 79.6 to 86.4	84.1 Percentage of Participants Interval 80.6 to 87.2	82.6 Percentage of Participants Interval 79.0 to 85.8	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	86.0 Percentage of Participants Interval 82.6 to 88.9	84.1 Percentage of Participants Interval 80.6 to 87.2	82.8 Percentage of Participants Interval 79.2 to 86.0	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	82.8 Percentage of Participants Interval 79.2 to 86.0	82.4 Percentage of Participants Interval 78.8 to 85.7	83.4 Percentage of Participants Interval 79.9 to 86.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	67.4 Percentage of Participants Interval 63.1 to 71.5	67.3 Percentage of Participants Interval 63.0 to 71.4	63.8 Percentage of Participants Interval 59.5 to 68.0	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	83.8 Percentage of Participants Interval 80.3 to 86.9	85.1 Percentage of Participants Interval 81.6 to 88.1	84.4 Percentage of Participants Interval 80.9 to 87.4	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	91.1 Percentage of Participants Interval 88.2 to 93.4	89.2 Percentage of Participants Interval 86.2 to 91.8	90.3 Percentage of Participants Interval 87.4 to 92.7	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	90.9 Percentage of Participants Interval 88.0 to 93.3	90.8 Percentage of Participants Interval 88.0 to 93.2	90.1 Percentage of Participants Interval 87.2 to 92.6	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	58.5 Percentage of Participants Interval 54.0 to 62.9	58.6 Percentage of Participants Interval 54.1 to 62.9	59.3 Percentage of Participants Interval 54.9 to 63.6	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	84.2 Percentage of Participants Interval 80.7 to 87.3	79.5 Percentage of Participants Interval 75.7 to 82.9	84.2 Percentage of Participants Interval 80.7 to 87.3	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	89.0 Percentage of Participants Interval 85.9 to 91.6	88.8 Percentage of Participants Interval 85.8 to 91.5	86.3 Percentage of Participants Interval 83.0 to 89.2	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	77.6 Percentage of Participants Interval 73.7 to 81.2	77.1 Percentage of Participants Interval 73.2 to 80.7	78.6 Percentage of Participants Interval 74.8 to 82.1	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	81.1 Percentage of Participants Interval 77.4 to 84.5	80.9 Percentage of Participants Interval 77.2 to 84.2	79.6 Percentage of Participants Interval 75.9 to 83.1	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	80.5 Percentage of Participants Interval 76.8 to 83.9	82.7 Percentage of Participants Interval 79.1 to 85.9	81.4 Percentage of Participants Interval 77.8 to 84.7	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	73.2 Percentage of Participants Interval 69.1 to 77.1	72.5 Percentage of Participants Interval 68.4 to 76.4	74.7 Percentage of Participants Interval 70.6 to 78.4	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	90.3 Percentage of Participants Interval 87.3 to 92.7	91.0 Percentage of Participants Interval 88.2 to 93.4	87.7 Percentage of Participants Interval 84.6 to 90.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	72.9 Percentage of Participants Interval 68.7 to 76.7	76.1 Percentage of Participants Interval 72.1 to 79.8	74.8 Percentage of Participants Interval 70.8 to 78.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	85.8 Percentage of Participants Interval 82.4 to 88.7	84.3 Percentage of Participants Interval 80.8 to 87.3	82.4 Percentage of Participants Interval 78.8 to 85.6	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	73.5 Percentage of Participants Interval 69.4 to 77.3	71.7 Percentage of Participants Interval 67.6 to 75.6	73.7 Percentage of Participants Interval 69.6 to 77.5	—
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	67.8 Percentage of Participants Interval 63.5 to 71.9	66.7 Percentage of Participants Interval 62.4 to 70.8	64.2 Percentage of Participants Interval 59.8 to 68.3	—

SECONDARY outcome

Timeframe: Day 30

Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

Outcome measures

Outcome measures
Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Serotype 6A	6849.6 Titers Interval 6120.8 to 7665.0	6009.2 Titers Interval 5348.8 to 6751.0	6724.3 Titers Interval 5967.6 to 7577.0	—
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Serotype 6C	3972.7 Titers Interval 3501.8 to 4506.9	3421.5 Titers Interval 3006.5 to 3893.8	3750.9 Titers Interval 3298.0 to 4265.9	—
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Serotype 15B	11799.5 Titers Interval 10317.9 to 13493.8	10062.4 Titers Interval 8838.3 to 11456.1	11139.5 Titers Interval 9619.7 to 12899.4	—
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots Serotype 15C	13079.8 Titers Interval 11543.5 to 14820.6	11332.5 Titers Interval 9905.9 to 12964.7	11290.9 Titers Interval 9805.6 to 13001.2	—

Adverse Events

V116 Lot 1

Serious events: 8 serious events

Other events: 428 other events

Deaths: 0 deaths

V116 Lot 2

Serious events: 5 serious events

Other events: 415 other events

Deaths: 0 deaths

V116 Lot 3

Serious events: 1 serious events

Other events: 421 other events

Deaths: 0 deaths

PPSV23

Serious events: 6 serious events

Other events: 388 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V116 Lot 1 n=539 participants at risk Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=536 participants at risk Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=541 participants at risk Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 n=541 participants at risk Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
General disorders Fatigue	38.2% 206/539 • Number of events 206 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	34.3% 184/536 • Number of events 186 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	34.6% 187/541 • Number of events 188 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	34.0% 184/541 • Number of events 186 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.
General disorders Injection site erythema	13.7% 74/539 • Number of events 74 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	14.7% 79/536 • Number of events 80 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	13.1% 71/541 • Number of events 71 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	7.6% 41/541 • Number of events 41 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.
General disorders Injection site pain	72.9% 393/539 • Number of events 394 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	72.9% 391/536 • Number of events 392 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	73.9% 400/541 • Number of events 401 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	60.6% 328/541 • Number of events 328 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.
General disorders Injection site swelling	12.6% 68/539 • Number of events 68 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	15.3% 82/536 • Number of events 82 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	11.8% 64/541 • Number of events 64 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	7.6% 41/541 • Number of events 41 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.
Musculoskeletal and connective tissue disorders Myalgia	18.2% 98/539 • Number of events 98 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	14.0% 75/536 • Number of events 75 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	17.6% 95/541 • Number of events 95 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	9.1% 49/541 • Number of events 49 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.
Nervous system disorders Headache	30.6% 165/539 • Number of events 172 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	28.7% 154/536 • Number of events 166 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	28.5% 154/541 • Number of events 163 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.	24.2% 131/541 • Number of events 140 • Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination according to the vaccination they received. One participant randomized to the V116 Lot 1 arm incorrectly received V116 Lot 3, one participant randomized into the V116 Lot 2 arm incorrectly received V116 Lot 1,and one participant randomized into the V116 Lot 2 arm incorrectly received PPSV23.

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	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	3935.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3812.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3765.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	6396.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6630.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6374.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	16339.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	16676.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	15302.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	11638.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	10614.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11346.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	37994.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	34227.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	35182.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	327.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	299.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	318.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	6901.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6014.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6641.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	7219.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6201.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6657.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	18747.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	17201.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	18557.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	7570.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	7796.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	7330.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	7478.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6803.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	7329.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	10698.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	10253.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	10692.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	13133.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11441.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11177.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	9239.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	9550.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	9530.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	17185.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	17718.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	16886.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	3187.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3123.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3368.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	8437.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8459.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8322.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	2964.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2435.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3035.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	4861.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4783.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4758.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	9052.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8831.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8870.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	12971.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	12586.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	12494.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—

Measure	V116 Lot 1 n=1617 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 9N	18166.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	19031.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 15A	10520.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2608.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 15C	11922.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4112.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 17F	17330.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	10159.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 23A	8428.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1056.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 23B	2825.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	119.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 3	316.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	339.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 6A	6491.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1866.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 7F	6702.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5058.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 8	3847.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4543.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 10A	7618.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5763.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 11A	6494.4 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3728.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 12F	7196.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5207.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 16F	9415.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2532.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 19A	3222.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3474.7 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 20A	16183.8 Titers NA means that per protocol, no within-group MOD were planned or calculated.	10994.2 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 22F	11118.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8308.0 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 24F	4892.9 Titers NA means that per protocol, no within-group MOD were planned or calculated.	250.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 31	8865.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	654.5 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 33F	35684.3 Titers NA means that per protocol, no within-group MOD were planned or calculated.	42515.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 35B	12798.6 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3452.1 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—	—

Measure	V116 Lot 1 n=539 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=538 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 7F	5.13 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 8	10.32 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	10.52 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	10.42 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15C	14.32 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.54 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.85 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 17F	14.05 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.37 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.14 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 19A	7.70 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	8.51 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23B	6.77 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.65 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.39 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 24F	4.32 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.55 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 31	3.47 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.47 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 3	0.83 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.85 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.87 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 6A	5.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.84 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 9N	5.37 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.11 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.03 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 10A	9.63 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.52 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 11A	6.33 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.28 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.21 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 12F	1.65 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.75 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.65 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 15A	13.63 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.00 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	14.20 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 16F	1.77 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.96 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 20A	13.54 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	14.18 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	14.09 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 22F	7.02 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 23A	4.26 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 33F	8.03 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	8.00 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots Serotype 35B	11.84 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	11.56 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	11.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—

Measure	V116 Lot 1 n=1617 Participants Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.	V116 Lot 2 n=540 Participants Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.	V116 Lot 3 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.	PPSV23 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 22F	7.04 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 23A	4.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.53 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 19A	8.01 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 3	0.85 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.77 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 6A	5.67 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.45 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 7F	5.19 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.36 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 8	10.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	12.85 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 9N	5.51 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.41 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 10A	9.58 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.52 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 11A	6.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.55 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 12F	1.69 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.20 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 15A	13.55 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 15C	13.90 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 16F	1.91 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.30 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 17F	13.46 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.28 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 20A	13.82 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.03 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 23B	6.96 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.21 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 24F	4.44 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.31 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 31	3.62 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.38 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 33F	8.00 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.82 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 Serotype 35B	11.71 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.66 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—	—