Trial Outcomes & Findings for Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) (NCT NCT05569954)

Last Updated: 2026-02-02

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1484 participants

Primary outcome timeframe

Up to 5 days postvaccination

Results posted on

2026-02-02

Participant Flow

1484 participants were randomized in the base study. Additionally, a subgroup of the first 700 participants randomized in the base study to either V116 or PPSV23 were followed for an additional 18 months after completing Visit 5 as part of an immunogenicity substudy extension. 80 participants enrolled at selected study sites were followed for an additional 6 months after completing Visit 5 as part of a PBMC substudy extension. These substudies investigated exploratory objectives.

Participant milestones

Participant milestones
Measure	PPSV23 Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1 in the Base Study. Selected participants were followed for an additional 18 months as a part of the immunogenicity substudy extension. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	V116 Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of the immunogenicity substudy extension. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.
Base Study STARTED	743	741
Base Study Vaccinated	741	739
Base Study COMPLETED	735	733
Base Study NOT COMPLETED	8	8
Immunogenicity Substudy Extension STARTED	350	350
Immunogenicity Substudy Extension COMPLETED	338	335
Immunogenicity Substudy Extension NOT COMPLETED	12	15
PBMC Substudy Extension STARTED	39	41
PBMC Substudy Extension COMPLETED	39	39
PBMC Substudy Extension NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PPSV23 Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1 in the Base Study. Selected participants were followed for an additional 18 months as a part of the immunogenicity substudy extension. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	V116 Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of the immunogenicity substudy extension. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.
Base Study Lost to Follow-up	4	3
Base Study Protocol Violation	2	1
Base Study Withdrawal by Subject	2	4
Immunogenicity Substudy Extension Lost to Follow-up	4	3
Immunogenicity Substudy Extension Randomized by mistake without study treatment	2	0
Immunogenicity Substudy Extension Withdrawal by Subject	5	12
Immunogenicity Substudy Extension Non-Study pneumococcal vaccine administered	1	0
PBMC Substudy Extension Withdrawal by Subject	0	2

Baseline Characteristics

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Base Study: V116 n=741 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=743 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.	Total n=1484 Participants Total of all reporting groups
Age, Continuous	63.9 Years STANDARD_DEVIATION 8.4 • n=13 Participants	63.7 Years STANDARD_DEVIATION 8.3 • n=15 Participants	63.8 Years STANDARD_DEVIATION 8.3 • n=28 Participants
Sex: Female, Male Female	332 Participants n=13 Participants	333 Participants n=15 Participants	665 Participants n=28 Participants
Sex: Female, Male Male	409 Participants n=13 Participants	410 Participants n=15 Participants	819 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	151 Participants n=13 Participants	162 Participants n=15 Participants	313 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	579 Participants n=13 Participants	571 Participants n=15 Participants	1150 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=13 Participants	10 Participants n=15 Participants	21 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=13 Participants	5 Participants n=15 Participants	9 Participants n=28 Participants
Race (NIH/OMB) Asian	151 Participants n=13 Participants	140 Participants n=15 Participants	291 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	9 Participants n=13 Participants	3 Participants n=15 Participants	12 Participants n=28 Participants
Race (NIH/OMB) Black or African American	2 Participants n=13 Participants	2 Participants n=15 Participants	4 Participants n=28 Participants
Race (NIH/OMB) White	455 Participants n=13 Participants	469 Participants n=15 Participants	924 Participants n=28 Participants
Race (NIH/OMB) More than one race	119 Participants n=13 Participants	124 Participants n=15 Participants	243 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=28 Participants

PRIMARY outcome

Timeframe: Up to 5 days postvaccination

Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site erythema	4.7 Percentage of Participants	6.3 Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site pain	39.0 Percentage of Participants	35.2 Percentage of Participants
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site swelling	4.9 Percentage of Participants	4.3 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 5 days postvaccination

Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With Solicited Systemic AEs Fatigue	16.5 Percentage of Participants	15.7 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Headache	13.7 Percentage of Participants	12.0 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Myalgia	5.3 Percentage of Participants	5.9 Percentage of Participants
Percentage of Participants With Solicited Systemic AEs Pyrexia	1.1 Percentage of Participants	1.3 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 6 months postvaccination

Population: All randomized participants that received a vaccination. Participants are included in the group corresponding to the vaccination received.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Day 30 postvaccination

Population: Per protocol, all randomized participants who were vaccinated 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), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.

Outcome measures

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 35B	63.8 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.2 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 6A	79.1 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	53.0 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 15A	69.7 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	30.3 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 15C	87.9 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	76.2 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 16F	63.2 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	20.3 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 23A	70.6 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	34.7 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 23B	86.6 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	44.1 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 24F	50.5 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	14.6 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116 31	74.4 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	18.3 Percentage of Participants NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

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: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.

OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs 6C	52.7 Percentage of Participants Interval 48.7 to 56.7	—
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs 15B	72.6 Percentage of Participants Interval 68.8 to 76.2	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 3	7.5 Ratio Interval 6.8 to 8.3	6.8 Ratio Interval 6.2 to 7.5
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 7F	18.3 Ratio Interval 15.8 to 21.1	14.0 Ratio Interval 12.2 to 16.1
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 8	34.3 Ratio Interval 29.6 to 39.8	28.8 Ratio Interval 25.1 to 33.0
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 9N	11.3 Ratio Interval 10.0 to 12.8	11.4 Ratio Interval 10.1 to 12.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 10A	16.6 Ratio Interval 14.3 to 19.1	10.9 Ratio Interval 9.5 to 12.4
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 11A	18.5 Ratio Interval 15.7 to 21.7	9.2 Ratio Interval 7.9 to 10.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 12F	89.2 Ratio Interval 78.1 to 101.8	58.1 Ratio Interval 50.5 to 66.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 17F	25.2 Ratio Interval 21.7 to 29.3	12.9 Ratio Interval 11.3 to 14.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 19A	10.2 Ratio Interval 9.1 to 11.4	7.2 Ratio Interval 6.5 to 8.0
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 20A	10.9 Ratio Interval 9.7 to 12.2	6.6 Ratio Interval 5.9 to 7.3
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 22F	20.5 Ratio Interval 17.4 to 24.1	12.3 Ratio Interval 10.5 to 14.3
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 33F	8.8 Ratio Interval 7.8 to 10.0	10.2 Ratio Interval 9.0 to 11.6
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 6A	19.5 Ratio Interval 16.9 to 22.4	5.5 Ratio Interval 4.8 to 6.3
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 15A	10.4 Ratio Interval 9.0 to 12.1	2.4 Ratio Interval 2.1 to 2.7
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 15C	49.4 Ratio Interval 42.4 to 57.6	17.3 Ratio Interval 15.1 to 19.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 16F	7.0 Ratio Interval 6.3 to 7.8	1.8 Ratio Interval 1.6 to 1.9
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 23A	13.9 Ratio Interval 11.7 to 16.5	2.7 Ratio Interval 2.2 to 3.2
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 23B	53.9 Ratio Interval 45.9 to 63.3	4.5 Ratio Interval 3.9 to 5.2
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 24F	5.5 Ratio Interval 4.8 to 6.3	1.6 Ratio Interval 1.4 to 1.8
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 31	19.5 Ratio Interval 16.7 to 22.8	1.7 Ratio Interval 1.5 to 1.9
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116 35B	7.0 Ratio Interval 6.3 to 7.8	1.1 Ratio Interval 1.1 to 1.2

SECONDARY outcome

Timeframe: Day 30 postvaccination

The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 3	5.3 Ratio Interval 5.0 to 5.8	4.7 Ratio Interval 4.4 to 5.0
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 7F	19.3 Ratio Interval 17.5 to 21.4	10.9 Ratio Interval 10.0 to 11.8
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 8	16.4 Ratio Interval 14.9 to 18.1	14.1 Ratio Interval 13.0 to 15.3
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 9N	20.1 Ratio Interval 18.1 to 22.4	13.3 Ratio Interval 12.2 to 14.5
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 10A	22.3 Ratio Interval 20.2 to 24.7	11.1 Ratio Interval 10.2 to 12.1
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 11A	10.9 Ratio Interval 9.8 to 12.0	5.0 Ratio Interval 4.7 to 5.4
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 12F	20.5 Ratio Interval 18.4 to 22.9	10.6 Ratio Interval 9.5 to 11.7
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 17F	25.5 Ratio Interval 23.1 to 28.1	10.8 Ratio Interval 9.9 to 11.8
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 19A	7.8 Ratio Interval 7.1 to 8.6	5.3 Ratio Interval 4.9 to 5.7
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 20A	15.8 Ratio Interval 14.4 to 17.3	8.6 Ratio Interval 7.9 to 9.3
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 22F	19.1 Ratio Interval 17.3 to 21.2	11.0 Ratio Interval 10.0 to 12.1
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 33F	14.4 Ratio Interval 13.1 to 15.8	12.0 Ratio Interval 11.0 to 13.0
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 6A	17.1 Ratio Interval 15.3 to 19.0	4.6 Ratio Interval 4.2 to 5.1
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 15A	27.5 Ratio Interval 24.9 to 30.4	3.1 Ratio Interval 2.9 to 3.4
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 15C	30.1 Ratio Interval 27.1 to 33.4	8.8 Ratio Interval 8.0 to 9.6
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 16F	15.4 Ratio Interval 14.1 to 16.9	1.6 Ratio Interval 1.5 to 1.7
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 23A	20.4 Ratio Interval 18.4 to 22.6	2.8 Ratio Interval 2.6 to 3.0
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 23B	13.3 Ratio Interval 12.0 to 14.7	2.9 Ratio Interval 2.7 to 3.1
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 24F	23.0 Ratio Interval 20.8 to 25.6	1.1 Ratio Interval 1.1 to 1.1
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 31	13.0 Ratio Interval 11.9 to 14.3	1.6 Ratio Interval 1.5 to 1.7
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116 35B	16.8 Ratio Interval 15.3 to 18.5	1.1 Ratio Interval 1.0 to 1.1

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 3	69.2 Percentage of Participants Interval 65.4 to 72.9	66.9 Percentage of Participants Interval 62.9 to 70.7
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 7F	75.2 Percentage of Participants Interval 71.7 to 78.5	69.9 Percentage of Participants Interval 66.2 to 73.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 8	83.6 Percentage of Participants Interval 80.5 to 86.3	85.4 Percentage of Participants Interval 82.5 to 88.0
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 9N	72.3 Percentage of Participants Interval 68.6 to 75.9	73.3 Percentage of Participants Interval 69.5 to 76.8
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 10A	74.7 Percentage of Participants Interval 71.1 to 78.1	66.5 Percentage of Participants Interval 62.6 to 70.2
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 11A	72.1 Percentage of Participants Interval 68.4 to 75.5	58.8 Percentage of Participants Interval 54.9 to 62.6
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 12F	93.3 Percentage of Participants Interval 91.1 to 95.0	90.7 Percentage of Participants Interval 88.3 to 92.8
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 17F	84.1 Percentage of Participants Interval 80.9 to 87.0	71.8 Percentage of Participants Interval 68.0 to 75.3
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 19A	70.9 Percentage of Participants Interval 67.3 to 74.3	64.1 Percentage of Participants Interval 60.3 to 67.7
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 20A	71.0 Percentage of Participants Interval 67.5 to 74.4	58.1 Percentage of Participants Interval 54.3 to 61.8
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 22F	76.5 Percentage of Participants Interval 72.9 to 79.8	67.2 Percentage of Participants Interval 63.3 to 70.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 33F	66.2 Percentage of Participants Interval 62.2 to 70.0	70.9 Percentage of Participants Interval 67.1 to 74.5
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 6A	79.1 Percentage of Participants Interval 75.7 to 82.2	53.0 Percentage of Participants Interval 49.0 to 57.0
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 15A	69.7 Percentage of Participants Interval 65.6 to 73.6	30.3 Percentage of Participants Interval 26.4 to 34.5
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 15C	87.9 Percentage of Participants Interval 85.1 to 90.3	76.2 Percentage of Participants Interval 72.7 to 79.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 16F	63.2 Percentage of Participants Interval 59.3 to 67.1	20.3 Percentage of Participants Interval 17.2 to 23.7
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 23A	70.6 Percentage of Participants Interval 66.3 to 74.6	34.7 Percentage of Participants Interval 30.2 to 39.5
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 23B	86.6 Percentage of Participants Interval 83.7 to 89.1	44.1 Percentage of Participants Interval 40.2 to 48.1
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 24F	50.5 Percentage of Participants Interval 46.2 to 54.7	14.6 Percentage of Participants Interval 11.6 to 18.0
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 31	74.4 Percentage of Participants Interval 70.8 to 77.7	18.3 Percentage of Participants Interval 15.4 to 21.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116 35B	63.8 Percentage of Participants Interval 60.0 to 67.5	5.2 Percentage of Participants Interval 3.6 to 7.1

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 30 postvaccination

The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 3	59.8 Percentage of Participants Interval 56.1 to 63.4	54.7 Percentage of Participants Interval 51.0 to 58.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 7F	84.8 Percentage of Participants Interval 81.9 to 87.4	79.7 Percentage of Participants Interval 76.6 to 82.6
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 8	84.4 Percentage of Participants Interval 81.5 to 87.0	86.5 Percentage of Participants Interval 83.7 to 88.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 9N	85.5 Percentage of Participants Interval 82.7 to 88.0	83.2 Percentage of Participants Interval 80.3 to 85.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 10A	88.9 Percentage of Participants Interval 86.3 to 91.1	81.1 Percentage of Participants Interval 78.1 to 83.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 11A	76.8 Percentage of Participants Interval 73.5 to 79.8	56.6 Percentage of Participants Interval 52.8 to 60.2
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 12F	86.5 Percentage of Participants Interval 83.7 to 88.9	73.7 Percentage of Participants Interval 70.4 to 76.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 17F	91.0 Percentage of Participants Interval 88.6 to 93.0	79.6 Percentage of Participants Interval 76.5 to 82.5
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 19A	63.9 Percentage of Participants Interval 60.3 to 67.5	58.5 Percentage of Participants Interval 54.8 to 62.2
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 33F	83.0 Percentage of Participants Interval 80.0 to 85.7	83.5 Percentage of Participants Interval 80.6 to 86.2
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 6A	81.4 Percentage of Participants Interval 78.3 to 84.2	47.3 Percentage of Participants Interval 43.6 to 51.1
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 15C	90.7 Percentage of Participants Interval 88.3 to 92.7	72.1 Percentage of Participants Interval 68.6 to 75.3
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 16F	83.8 Percentage of Participants Interval 80.9 to 86.4	11.3 Percentage of Participants Interval 9.1 to 13.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 23A	85.9 Percentage of Participants Interval 83.1 to 88.4	29.9 Percentage of Participants Interval 26.6 to 33.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 23B	78.9 Percentage of Participants Interval 75.7 to 81.8	33.1 Percentage of Participants Interval 29.7 to 36.7
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 24F	88.2 Percentage of Participants Interval 85.5 to 90.4	1.7 Percentage of Participants Interval 0.9 to 2.9
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 31	82.0 Percentage of Participants Interval 78.9 to 84.7	11.6 Percentage of Participants Interval 9.3 to 14.2
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 35B	85.1 Percentage of Participants Interval 82.2 to 87.6	2.1 Percentage of Participants Interval 1.2 to 3.4
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 22F	85.4 Percentage of Participants Interval 82.5 to 87.9	77.5 Percentage of Participants Interval 74.3 to 80.5
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 15A	91.3 Percentage of Participants Interval 88.9 to 93.2	34.2 Percentage of Participants Interval 30.7 to 37.8
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116 20A	85.5 Percentage of Participants Interval 82.7 to 88.0	73.3 Percentage of Participants Interval 69.9 to 76.5

Adverse Events

PBMC Sub-study: V116

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PBMC Sub-study: PPSV23

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Base Study: V116

Serious events: 22 serious events

Other events: 399 other events

Deaths: 0 deaths

Base Study: PPSV23

Serious events: 18 serious events

Other events: 364 other events

Deaths: 0 deaths

Immunogenicity Substudy: V116

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Immunogenicity Substudy: PPSV23

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PBMC Sub-study: V116 n=41 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	PBMC Sub-study: PPSV23 n=39 participants at risk Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1 in the Base Study. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	Base Study: V116 n=739 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 participants at risk Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.	Immunogenicity Substudy: V116 n=349 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of an immunogenicity substudy extension.	Immunogenicity Substudy: PPSV23 n=348 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of PPSV23 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of an immunogenicity substudy extension.
Ear and labyrinth disorders Vertigo	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Cardiac disorders Acute myocardial infarction	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Cardiac disorders Extrasystoles	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Cardiac disorders Mitral valve incompetence	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Cardiac disorders Sinus bradycardia	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Endocrine disorders Thyroid mass	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
General disorders Chest pain	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Hepatobiliary disorders Cholecystitis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Hepatobiliary disorders Cholelithiasis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Abdominal infection	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations COVID-19	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Gastroenteritis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Influenza	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Osteomyelitis chronic	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Pneumonia	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Pyelonephritis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Respiratory tract infection	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Infections and infestations Urinary tract infection	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Nervous system disorders Paraesthesia	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Nervous system disorders Peroneal nerve palsy	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Nervous system disorders Syncope	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Renal and urinary disorders Acute kidney injury	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Reproductive system and breast disorders Testicular pain	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.14% 1/739 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/741 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Vascular disorders Deep vein thrombosis	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/739 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.13% 1/741 • Number of events 1 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.

Other adverse events

Other adverse events
Measure	PBMC Sub-study: V116 n=41 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	PBMC Sub-study: PPSV23 n=39 participants at risk Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1 in the Base Study. Selected participants were followed for an additional 6 months as a part of a PBMC substudy extension.	Base Study: V116 n=739 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 participants at risk Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.	Immunogenicity Substudy: V116 n=349 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of an immunogenicity substudy extension.	Immunogenicity Substudy: PPSV23 n=348 participants at risk Participants received a single intramuscular (IM) vaccination of 0.5 mL of PPSV23 on Day 1 in the base study. Selected participants were followed for an additional 18 months as a part of an immunogenicity substudy extension.
General disorders Fatigue	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	16.5% 122/739 • Number of events 127 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	15.9% 118/741 • Number of events 119 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
General disorders Injection site erythema	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	7.8% 58/739 • Number of events 59 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	6.3% 47/741 • Number of events 47 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
General disorders Injection site pain	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	40.7% 301/739 • Number of events 303 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	35.2% 261/741 • Number of events 261 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
General disorders Injection site swelling	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	6.5% 48/739 • Number of events 48 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	4.3% 32/741 • Number of events 32 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	5.8% 43/739 • Number of events 43 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	6.2% 46/741 • Number of events 47 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.
Nervous system disorders Headache	0.00% 0/41 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/39 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	16.8% 124/739 • Number of events 139 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	14.2% 105/741 • Number of events 117 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/349 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.	0.00% 0/348 • Up to 24 months postvaccination. Nonserious AEs through Day 30 postvaccination and all SAEs and deaths through 6 months were collected and reported for all randomized participants who received a vaccination. As pre-specified in the protocol, there were no safety outcome measures associated with the substudies. Per protocol, beyond 6 months postvaccination, participants in the substudies were only assessed for vaccine-related SAEs, deaths (any cause), and any AEs related to a protocol-specified blood draw.

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 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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER

Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 3	230.4 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	211.5 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 7F	4876.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	3314.6 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 8	3379.6 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	2882.1 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 9N	7346.6 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	6545.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 10A	4382.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	2818.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 11A	3711.1 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1809.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 12F	3031.8 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1854.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 17F	8215.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	4060.5 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 19A	2670.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1879.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 20A	6966.1 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	4208.4 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 22F	4724.1 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	3084.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 33F	15497.3 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	17483.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 6A	3193.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	964.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 15A	6746.5 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1462.1 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 15C	7604.8 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	2605.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 16F	6675.4 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1482.2 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 23A	4804.2 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	837.2 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 23B	2252.6 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	137.2 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 24F	4568.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1346.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 31	5040.7 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	423.9 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116 35B	10707.5 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1735.0 Titers NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.

Measure	Base Study: V116 n=739 Participants Participants received a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Base Study: PPSV23 n=741 Participants Participants received a single IM vaccination of 0.5 mL of PPSV23 on Day 1.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 3	0.79 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.69 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 7F	9.35 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.02 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 8	13.83 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	11.85 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 9N	11.21 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	7.23 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 10A	15.05 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	7.41 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 11A	8.83 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	4.01 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 12F	2.28 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1.14 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 17F	16.39 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	6.85 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 19A	9.54 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	6.42 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 20A	22.97 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	12.32 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 22F	5.32 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	3.00 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 33F	19.12 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	15.70 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 6A	5.79 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1.53 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 15A	17.98 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	2.01 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 15C	19.27 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	5.61 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 16F	3.48 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.35 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 23A	4.21 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.56 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 23B	5.74 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1.20 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 24F	8.52 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.40 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 31	3.48 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	0.40 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116 35B	22.26 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.	1.43 μg/mL NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.