Trial Outcomes & Findings for A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001) (NCT NCT04168190)

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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

600 participants

Primary outcome timeframe

Up to 5 days post-vaccination

Results posted on

2022-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: V116 0.5 mL Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1	Phase 2: V116 Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2	Phase 2: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2
Overall Study STARTED	30	30	30	254	256
Overall Study Treated	30	30	30	254	254
Overall Study COMPLETED	29	29	30	244	247
Overall Study NOT COMPLETED	1	1	0	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: V116 0.5 mL Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 2: V116 Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2	Phase 2: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2
Overall Study Lost to Follow-up	0	1	7	5
Overall Study Withdrawal by Subject	1	0	2	4
Overall Study Death	0	0	1	0

Baseline Characteristics

A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1	Phase 2: V116 n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2	Phase 2: Pneumovax™23 n=256 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2	Total n=600 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 7.4 • n=5 Participants	34.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	35.2 years STANDARD_DEVIATION 8.2 • n=5 Participants	61.3 years STANDARD_DEVIATION 7.0 • n=4 Participants	61.2 years STANDARD_DEVIATION 7.3 • n=21 Participants	57.5 years STANDARD_DEVIATION 11.7 • n=10 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	142 Participants n=4 Participants	140 Participants n=21 Participants	341 Participants n=10 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	112 Participants n=4 Participants	116 Participants n=21 Participants	259 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	107 Participants n=4 Participants	107 Participants n=21 Participants	254 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	147 Participants n=4 Participants	147 Participants n=21 Participants	344 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	25 Participants n=4 Participants	30 Participants n=21 Participants	69 Participants n=10 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	224 Participants n=4 Participants	220 Participants n=21 Participants	514 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

Population: All randomized participants enrolled in Phase 1 portion who received study vaccination

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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) Injection site erythema	10.0 Percentage of participants	23.3 Percentage of participants	20.0 Percentage of participants
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) Injection site pain	73.3 Percentage of participants	76.7 Percentage of participants	56.7 Percentage of participants
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) Injection site swelling	20.0 Percentage of participants	16.7 Percentage of participants	13.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

Population: All randomized participants enrolled in Phase 1 portion who received study vaccination

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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Percentage of Participants With a Solicited Systemic AE Headache	30.0 Percentage of participants	20.0 Percentage of participants	16.7 Percentage of participants
Phase 1: Percentage of Participants With a Solicited Systemic AE Fatigue	26.7 Percentage of participants	26.7 Percentage of participants	16.7 Percentage of participants
Phase 1: Percentage of Participants With a Solicited Systemic AE Arthralgia	16.7 Percentage of participants	10.0 Percentage of participants	6.7 Percentage of participants
Phase 1: Percentage of Participants With a Solicited Systemic AE Myalgia	26.7 Percentage of participants	30.0 Percentage of participants	13.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 195

Population: All randomized participants enrolled in Phase 1 portion who received study vaccination

A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

Population: All randomized participants enrolled in Phase 2 portion who received study vaccination

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. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=254 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Percentage of Participants With a Solicited Injection-site AE Injection site erythema	8.7 Percentage of Participants	6.7 Percentage of Participants	—
Phase 2: Percentage of Participants With a Solicited Injection-site AE Injection site pain	46.5 Percentage of Participants	37.8 Percentage of Participants	—
Phase 2: Percentage of Participants With a Solicited Injection-site AE Injection site swelling	11.0 Percentage of Participants	7.9 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to 5 days post-vaccination

Population: All randomized participants enrolled in Phase 2 portion who received study vaccination

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. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=254 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Percentage of Participants With a Solicited Systemic AE Fatigue	19.3 Percentage of Participants	12.2 Percentage of Participants	—
Phase 2: Percentage of Participants With a Solicited Systemic AE Arthralgia	4.3 Percentage of Participants	4.3 Percentage of Participants	—
Phase 2: Percentage of Participants With a Solicited Systemic AE Myalgia	11.0 Percentage of Participants	9.4 Percentage of Participants	—
Phase 2: Percentage of Participants With a Solicited Systemic AE Headache	16.9 Percentage of Participants	13.4 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 293

Population: All randomized participants enrolled in Phase 2 portion who received study vaccination

An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=254 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Percentage of Participants With Vaccine-related SAEs	0.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=252 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 3	226.26 Titers NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	226.21 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 7F	3535.44 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2906.76 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 19A	2388.12 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2116.13 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 22F	8213.56 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5192.20 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 33F	28129.21 Titers NA means that per protocol, no within-group MOD were planned or calculated.	29974.55 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 8	1504.65 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1526.78 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 9N	10327.15 Titers NA means that per protocol, no within-group MOD were planned or calculated.	9106.32 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 10A	6062.22 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5092.07 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 11A	2840.38 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1252.27 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 12F	2549.45 Titers NA means that per protocol, no within-group MOD were planned or calculated.	991.10 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 17F	18394.13 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11249.90 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 20A	9305.32 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5068.03 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—

PRIMARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=252 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 6A	2757.55 Titers NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	456.97 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 15A	11640.00 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1711.40 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 15C	12611.76 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4200.74 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 16F	9820.72 Titers NA means that per protocol, no within-group MOD were planned or calculated.	539.16 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 23A	11554.45 Titers NA means that per protocol, no within-group MOD were planned or calculated.	593.91 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 23B	3137.15 Titers NA means that per protocol, no within-group MOD were planned or calculated.	105.00 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 24F	7640.78 Titers NA means that per protocol, no within-group MOD were planned or calculated.	238.65 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 31	4461.98 Titers NA means that per protocol, no within-group MOD were planned or calculated.	127.84 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 Serotype 35B	15704.65 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1745.16 Titers NA means that per protocol, no within-group MOD were planned or calculated.	—

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

Serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 3	0.78 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	0.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.86 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 7F	3.33 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.39 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.98 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 19A	6.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	10.27 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.93 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 22F	5.27 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.14 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.16 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 33F	8.64 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	15.19 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	11.51 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 8	11.33 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	17.62 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	17.80 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 9N	5.40 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	8.60 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.26 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 10A	8.90 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.13 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.15 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 11A	4.50 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.44 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.93 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 12F	1.03 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.13 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 17F	11.54 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	15.71 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.48 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 20A	16.44 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	19.13 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 6A	6.32 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	8.08 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.47 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 15A	8.87 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	15.66 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.76 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 15C	16.33 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	18.26 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.71 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 16F	1.27 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.44 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.37 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 23A	4.02 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.03 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.43 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 23B	5.52 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.67 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.61 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 24F	3.39 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.79 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.42 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 31	2.68 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 Serotype 35	11.89 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	16.09 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 3	242.35 Titers NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	259.17 Titers NA means that per protocol, no within-group MOD were planned or calculated.	243.66 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 7F	4503.32 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5672.08 Titers NA means that per protocol, no within-group MOD were planned or calculated.	5122.36 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 19A	3312.61 Titers NA means that per protocol, no within-group MOD were planned or calculated.	4595.55 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3475.22 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 22F	21336.23 Titers NA means that per protocol, no within-group MOD were planned or calculated.	26003.97 Titers NA means that per protocol, no within-group MOD were planned or calculated.	12905.25 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 33F	62540.43 Titers NA means that per protocol, no within-group MOD were planned or calculated.	137389.68 Titers NA means that per protocol, no within-group MOD were planned or calculated.	72703.24 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 8	1830.31 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2321.18 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2598.16 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 9N	28204.72 Titers NA means that per protocol, no within-group MOD were planned or calculated.	26659.08 Titers NA means that per protocol, no within-group MOD were planned or calculated.	24483.35 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 10A	10338.92 Titers NA means that per protocol, no within-group MOD were planned or calculated.	12377.52 Titers NA means that per protocol, no within-group MOD were planned or calculated.	6623.80 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 11A	2531.25 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3152.05 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2836.72 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 12F	5171.95 Titers NA means that per protocol, no within-group MOD were planned or calculated.	7279.62 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3036.31 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 17F	48838.60 Titers NA means that per protocol, no within-group MOD were planned or calculated.	51152.97 Titers NA means that per protocol, no within-group MOD were planned or calculated.	24816.34 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 Serotype 20A	13910.60 Titers NA means that per protocol, no within-group MOD were planned or calculated.	17799.33 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11430.20 Titers NA means that per protocol, no within-group MOD were planned or calculated.

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 6A	7182.41 Titers NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	7407.66 Titers NA means that per protocol, no within-group MOD were planned or calculated.	513.88 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 15A	19337.39 Titers NA means that per protocol, no within-group MOD were planned or calculated.	24580.49 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2615.98 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 15C	20743.02 Titers NA means that per protocol, no within-group MOD were planned or calculated.	27242.11 Titers NA means that per protocol, no within-group MOD were planned or calculated.	9728.58 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 16F	11120.97 Titers NA means that per protocol, no within-group MOD were planned or calculated.	17201.69 Titers NA means that per protocol, no within-group MOD were planned or calculated.	2931.40 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 23A	26267.17 Titers NA means that per protocol, no within-group MOD were planned or calculated.	36793.08 Titers NA means that per protocol, no within-group MOD were planned or calculated.	1908.80 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 23B	5258.43 Titers NA means that per protocol, no within-group MOD were planned or calculated.	8684.75 Titers NA means that per protocol, no within-group MOD were planned or calculated.	220.48 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 24F	7593.39 Titers NA means that per protocol, no within-group MOD were planned or calculated.	11867.21 Titers NA means that per protocol, no within-group MOD were planned or calculated.	381.95 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 31	7417.79 Titers NA means that per protocol, no within-group MOD were planned or calculated.	7453.48 Titers NA means that per protocol, no within-group MOD were planned or calculated.	128.36 Titers NA means that per protocol, no within-group MOD were planned or calculated.
Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 Serotype 35B	21103.18 Titers NA means that per protocol, no within-group MOD were planned or calculated.	23826.47 Titers NA means that per protocol, no within-group MOD were planned or calculated.	3044.94 Titers NA means that per protocol, no within-group MOD were planned or calculated.

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days postvaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15C	37.97 Ratio Interval 13.68 to 105.4	58.39 Ratio Interval 20.58 to 165.67	10.58 Ratio Interval 6.14 to 18.23
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 3	12.90 Ratio Interval 8.95 to 18.59	10.68 Ratio Interval 6.27 to 18.18	10.01 Ratio Interval 6.62 to 15.14
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 7F	15.64 Ratio Interval 6.94 to 35.23	19.68 Ratio Interval 9.96 to 38.87	34.18 Ratio Interval 15.67 to 74.56
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 19A	12.26 Ratio Interval 7.03 to 21.38	18.34 Ratio Interval 10.32 to 32.6	14.92 Ratio Interval 7.84 to 28.42
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 22F	92.21 Ratio Interval 38.88 to 218.7	81.76 Ratio Interval 32.42 to 206.23	32.64 Ratio Interval 14.59 to 73.04
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 33F	17.68 Ratio Interval 10.86 to 28.78	34.83 Ratio Interval 21.63 to 56.09	20.24 Ratio Interval 11.07 to 37.02
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 8	39.67 Ratio Interval 21.83 to 72.09	50.01 Ratio Interval 25.73 to 97.2	72.24 Ratio Interval 38.21 to 136.59
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 9N	22.91 Ratio Interval 10.93 to 48.0	19.80 Ratio Interval 8.34 to 47.04	27.38 Ratio Interval 13.87 to 54.03
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 10A	12.69 Ratio Interval 5.39 to 29.87	18.21 Ratio Interval 8.76 to 37.85	10.35 Ratio Interval 5.0 to 21.41
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 11A	7.46 Ratio Interval 3.4 to 16.39	8.23 Ratio Interval 4.46 to 15.21	7.64 Ratio Interval 4.2 to 13.93
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 12F	360.69 Ratio Interval 192.76 to 674.93	448.73 Ratio Interval 243.29 to 827.65	162.71 Ratio Interval 85.83 to 308.43
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 17F	36.57 Ratio Interval 17.73 to 75.45	37.33 Ratio Interval 20.19 to 69.04	20.54 Ratio Interval 11.7 to 36.08
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 20A	15.67 Ratio Interval 8.21 to 29.92	19.20 Ratio Interval 10.52 to 35.07	14.91 Ratio Interval 8.6 to 25.83
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 6A	311.54 Ratio Interval 171.83 to 565.18	375.42 Ratio Interval 194.76 to 723.64	20.95 Ratio Interval 9.44 to 46.47
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15A	31.56 Ratio Interval 12.49 to 79.74	29.31 Ratio Interval 13.47 to 63.79	5.53 Ratio Interval 2.96 to 10.35
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 16F	16.82 Ratio Interval 7.3 to 38.75	25.99 Ratio Interval 10.54 to 64.09	4.30 Ratio Interval 2.59 to 7.12
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 23A	380.08 Ratio Interval 136.77 to 1056.21	269.90 Ratio Interval 86.95 to 837.8	17.52 Ratio Interval 6.87 to 44.65
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 23B	99.58 Ratio Interval 36.09 to 274.72	157.02 Ratio Interval 61.06 to 403.76	5.39 Ratio Interval 2.92 to 9.95
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 24F	14.86 Ratio Interval 5.86 to 37.7	23.51 Ratio Interval 9.64 to 57.34	1.24 Ratio Interval 0.76 to 2.03
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 31	95.53 Ratio Interval 36.62 to 249.17	94.51 Ratio Interval 39.26 to 227.5	3.23 Ratio Interval 1.52 to 6.86
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 35B	13.68 Ratio Interval 7.26 to 25.79	12.56 Ratio Interval 8.48 to 18.61	1.73 Ratio Interval 1.45 to 2.06
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 6C	41.71 Ratio Interval 14.41 to 120.73	65.05 Ratio Interval 23.86 to 177.35	2.82 Ratio Interval 1.46 to 5.43
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15B	78.68 Ratio Interval 25.58 to 242.03	89.25 Ratio Interval 30.6 to 260.27	33.11 Ratio Interval 13.27 to 82.61
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 20B	3.78 Ratio Interval 1.97 to 7.26	4.17 Ratio Interval 2.05 to 8.47	5.01 Ratio Interval 2.46 to 10.23

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days post vaccination

Population: All randomized participants enrolled in Phase 1 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMCs for the serotypes in V116 and Pneumovax™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=30 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=29 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 n=30 Participants Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 3	5.36 Ratio Interval 3.9 to 7.35	5.94 Ratio Interval 4.05 to 8.71	4.97 Ratio Interval 3.39 to 7.27
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 7F	8.38 Ratio Interval 5.3 to 13.25	16.00 Ratio Interval 10.28 to 24.9	7.44 Ratio Interval 5.05 to 10.97
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 19A	4.67 Ratio Interval 3.03 to 7.21	7.28 Ratio Interval 4.63 to 11.45	3.66 Ratio Interval 2.66 to 5.04
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 22F	19.51 Ratio Interval 11.64 to 32.69	21.83 Ratio Interval 13.51 to 35.29	24.34 Ratio Interval 12.3 to 48.18
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 33F	9.33 Ratio Interval 5.62 to 15.49	16.28 Ratio Interval 10.36 to 25.58	11.75 Ratio Interval 7.66 to 18.03
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 8	13.86 Ratio Interval 8.94 to 21.49	22.89 Ratio Interval 15.29 to 34.27	25.99 Ratio Interval 15.35 to 44.0
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 9N	12.90 Ratio Interval 8.6 to 19.36	20.85 Ratio Interval 13.11 to 33.16	14.37 Ratio Interval 8.41 to 24.55
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 10A	11.36 Ratio Interval 6.61 to 19.52	16.10 Ratio Interval 9.76 to 26.57	9.58 Ratio Interval 6.94 to 13.24
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 11A	2.71 Ratio Interval 1.7 to 4.33	7.18 Ratio Interval 3.96 to 13.02	5.17 Ratio Interval 3.24 to 8.24
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 12F	10.35 Ratio Interval 6.36 to 16.85	22.71 Ratio Interval 13.35 to 38.61	9.75 Ratio Interval 5.37 to 17.71
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 17F	19.23 Ratio Interval 11.44 to 32.34	22.52 Ratio Interval 14.61 to 34.73	10.07 Ratio Interval 6.8 to 14.91
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 20A	10.81 Ratio Interval 6.67 to 17.5	11.18 Ratio Interval 7.38 to 16.93	5.60 Ratio Interval 3.58 to 8.77
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 6A	23.58 Ratio Interval 12.37 to 44.95	29.48 Ratio Interval 18.01 to 48.26	5.66 Ratio Interval 3.29 to 9.76
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 15A	14.61 Ratio Interval 8.07 to 26.45	28.84 Ratio Interval 17.91 to 46.44	3.02 Ratio Interval 1.87 to 4.88
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 15C	31.93 Ratio Interval 18.64 to 54.69	37.55 Ratio Interval 20.18 to 69.88	7.94 Ratio Interval 5.56 to 11.36
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 16F	4.39 Ratio Interval 2.71 to 7.11	10.80 Ratio Interval 7.22 to 16.15	1.69 Ratio Interval 1.16 to 2.45
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 23A	23.43 Ratio Interval 12.21 to 44.99	22.53 Ratio Interval 11.84 to 42.86	2.75 Ratio Interval 1.83 to 4.13
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 23B	9.03 Ratio Interval 4.99 to 16.36	15.56 Ratio Interval 8.88 to 27.27	2.66 Ratio Interval 1.92 to 3.68
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 24F	11.18 Ratio Interval 5.18 to 24.13	19.44 Ratio Interval 11.3 to 33.47	1.26 Ratio Interval 0.79 to 2.03
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 31	12.83 Ratio Interval 7.24 to 22.75	19.71 Ratio Interval 12.9 to 30.13	1.77 Ratio Interval 1.19 to 2.63
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 35B	9.77 Ratio Interval 5.7 to 16.73	11.33 Ratio Interval 7.01 to 18.31	0.96 Ratio Interval 0.86 to 1.06
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 6C	6.52 Ratio Interval 3.64 to 11.7	9.48 Ratio Interval 5.47 to 16.42	2.22 Ratio Interval 1.61 to 3.07
Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG Serotype 15B	12.54 Ratio Interval 6.73 to 23.36	11.96 Ratio Interval 6.32 to 22.65	8.05 Ratio Interval 5.67 to 11.42

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=252 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 3	0.78 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	0.72 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 7F	4.98 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.07 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 19A	7.77 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	6.26 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 22F	3.81 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.79 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 33F	11.89 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	13.82 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 8	9.86 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	10.30 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 9N	7.18 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.51 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 10A	10.78 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.89 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 11A	5.16 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.35 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 12F	1.56 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.68 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 17F	12.85 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.06 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 Serotype 20A	20.59 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	9.09 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—

SECONDARY outcome

Timeframe: 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=252 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=254 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 6A	4.06 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	1.07 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 15A	13.14 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.71 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 15C	11.91 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.62 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 16F	2.17 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.25 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 23A	3.32 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.42 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 23B	5.18 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.92 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 24F	6.11 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.25 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 31	3.15 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.31 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—
Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 Serotype 35B	24.55 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.34 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and at 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMT/Day 1 GMT.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=238 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=235 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 22F	52.66 Ratio Interval 37.4 to 74.14	46.34 Ratio Interval 33.34 to 64.41	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 23B	97.79 Ratio Interval 71.94 to 132.92	4.62 Ratio Interval 3.58 to 5.96	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 3	12.03 Ratio Interval 10.04 to 14.41	10.96 Ratio Interval 9.25 to 13.0	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 7F	31.07 Ratio Interval 22.87 to 42.22	22.52 Ratio Interval 17.23 to 29.45	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 19A	13.05 Ratio Interval 10.22 to 16.66	10.26 Ratio Interval 8.31 to 12.67	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 33F	13.47 Ratio Interval 10.47 to 17.32	14.04 Ratio Interval 11.23 to 17.53	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 8	39.06 Ratio Interval 30.34 to 50.28	40.06 Ratio Interval 31.59 to 50.8	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 9N	33.51 Ratio Interval 24.38 to 46.04	29.38 Ratio Interval 21.67 to 39.82	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 10A	12.34 Ratio Interval 8.79 to 17.31	8.12 Ratio Interval 6.03 to 10.94	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 11A	33.21 Ratio Interval 25.13 to 43.88	12.29 Ratio Interval 9.41 to 16.05	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 12F	150.08 Ratio Interval 112.83 to 199.61	57.03 Ratio Interval 42.59 to 76.35	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 17F	40.71 Ratio Interval 30.35 to 54.6	25.68 Ratio Interval 19.56 to 33.73	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 20A	20.48 Ratio Interval 16.11 to 26.02	12.16 Ratio Interval 9.58 to 15.43	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 6A	79.16 Ratio Interval 58.28 to 107.51	11.30 Ratio Interval 8.42 to 15.16	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15A	26.66 Ratio Interval 20.16 to 35.25	3.93 Ratio Interval 3.18 to 4.87	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15C	65.18 Ratio Interval 46.91 to 90.58	23.73 Ratio Interval 16.98 to 33.15	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 16F	56.50 Ratio Interval 41.53 to 76.85	3.54 Ratio Interval 2.61 to 4.81	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 23A	237.14 Ratio Interval 166.28 to 338.22	10.65 Ratio Interval 7.42 to 15.29	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 24F	48.78 Ratio Interval 35.07 to 67.84	1.52 Ratio Interval 1.18 to 1.97	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 31	92.00 Ratio Interval 66.09 to 128.07	3.25 Ratio Interval 2.51 to 4.21	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 35B	12.41 Ratio Interval 10.08 to 15.27	1.53 Ratio Interval 1.33 to 1.75	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 6C	19.41 Ratio Interval 13.65 to 27.61	4.24 Ratio Interval 3.09 to 5.84	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 15B	24.32 Ratio Interval 17.88 to 33.08	25.73 Ratio Interval 19.14 to 34.58	—
Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Serotype 20B	7.21 Ratio Interval 5.68 to 9.17	5.35 Ratio Interval 4.08 to 7.01	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

GMCs for each serotype common in V116 and Pneumovax™23 were measured using PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=240 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=239 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 23B	13.50 Ratio Interval 11.25 to 16.21	2.51 Ratio Interval 2.21 to 2.85	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 24F	25.20 Ratio Interval 20.48 to 31.02	1.08 Ratio Interval 1.02 to 1.14	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 3	5.23 Ratio Interval 4.52 to 6.06	4.56 Ratio Interval 3.98 to 5.21	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 7F	9.96 Ratio Interval 8.4 to 11.81	8.28 Ratio Interval 7.06 to 9.71	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 19A	5.29 Ratio Interval 4.51 to 6.21	4.12 Ratio Interval 3.6 to 4.71	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 22F	12.45 Ratio Interval 10.07 to 15.39	9.04 Ratio Interval 7.53 to 10.86	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 33F	9.94 Ratio Interval 8.26 to 11.97	11.63 Ratio Interval 9.87 to 13.71	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 8	14.53 Ratio Interval 11.92 to 17.72	15.51 Ratio Interval 13.06 to 18.4	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 9N	17.77 Ratio Interval 14.62 to 21.61	11.80 Ratio Interval 9.92 to 14.04	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 10A	17.32 Ratio Interval 14.41 to 20.82	9.29 Ratio Interval 7.92 to 10.9	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 11A	7.71 Ratio Interval 6.56 to 9.07	4.72 Ratio Interval 4.12 to 5.41	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 12F	13.72 Ratio Interval 11.13 to 16.91	6.14 Ratio Interval 5.11 to 7.37	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 17F	20.26 Ratio Interval 17.03 to 24.11	11.11 Ratio Interval 9.54 to 12.95	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 20A	14.95 Ratio Interval 12.53 to 17.84	6.30 Ratio Interval 5.41 to 7.33	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 6A	13.35 Ratio Interval 10.9 to 16.35	3.56 Ratio Interval 3.03 to 4.19	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 15A	23.94 Ratio Interval 19.89 to 28.81	3.02 Ratio Interval 2.63 to 3.47	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 15C	22.35 Ratio Interval 18.49 to 27.01	7.28 Ratio Interval 6.17 to 8.6	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 16F	12.42 Ratio Interval 10.62 to 14.52	1.51 Ratio Interval 1.37 to 1.66	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 23A	20.27 Ratio Interval 16.82 to 24.43	2.66 Ratio Interval 2.3 to 3.06	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 31	15.89 Ratio Interval 13.47 to 18.76	1.62 Ratio Interval 1.46 to 1.81	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 35B	18.72 Ratio Interval 15.89 to 22.05	1.04 Ratio Interval 0.98 to 1.1	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 6C	5.78 Ratio Interval 4.79 to 6.97	1.67 Ratio Interval 1.52 to 1.85	—
Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG Serotype 15B	9.95 Ratio Interval 8.28 to 11.95	8.87 Ratio Interval 7.52 to 10.47	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and 30 days post vaccination

Population: All randomized participants enrolled in Phase 2 portion without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses

The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model.

Outcome measures

Outcome measures
Measure	Phase 1: V116 0.5 mL n=238 Participants Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=235 Participants Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: Pneumovax™23 Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 3	74.8 Percentage of Participants Interval 68.8 to 80.2	75.7 Percentage of Participants Interval 69.7 to 81.1	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 7F	74.2 Percentage of Participants Interval 68.1 to 79.6	77.0 Percentage of Participants Interval 71.1 to 82.2	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 19A	66.9 Percentage of Participants Interval 60.6 to 72.9	67.1 Percentage of Participants Interval 60.7 to 73.1	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 22F	81.3 Percentage of Participants Interval 75.7 to 86.1	79.3 Percentage of Participants Interval 73.5 to 84.3	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 33F	68.4 Percentage of Participants Interval 62.0 to 74.3	75.7 Percentage of Participants Interval 69.5 to 81.1	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 8	80.9 Percentage of Participants Interval 75.2 to 85.7	85.5 Percentage of Participants Interval 80.3 to 89.7	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 9N	77.3 Percentage of Participants Interval 71.3 to 82.5	79.5 Percentage of Participants Interval 73.7 to 84.5	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 10A	59.9 Percentage of Participants Interval 52.4 to 67.1	55.2 Percentage of Participants Interval 47.5 to 62.7	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 11A	80.3 Percentage of Participants Interval 74.6 to 85.1	62.9 Percentage of Participants Interval 56.3 to 69.2	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 12F	90.2 Percentage of Participants Interval 85.4 to 93.8	82.9 Percentage of Participants Interval 77.3 to 87.6	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 17F	85.2 Percentage of Participants Interval 80.1 to 89.5	80.9 Percentage of Participants Interval 75.2 to 85.7	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 20A	83.6 Percentage of Participants Interval 78.3 to 88.1	69.4 Percentage of Participants Interval 63.0 to 75.2	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 6A	83.2 Percentage of Participants Interval 77.8 to 87.7	58.8 Percentage of Participants Interval 52.2 to 65.2	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 15A	86.6 Percentage of Participants Interval 81.3 to 90.8	39.3 Percentage of Participants Interval 32.7 to 46.3	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 15C	88.5 Percentage of Participants Interval 83.6 to 92.3	71.0 Percentage of Participants Interval 64.4 to 76.9	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 16F	85.4 Percentage of Participants Interval 80.1 to 89.7	30.2 Percentage of Participants Interval 24.2 to 36.8	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 23A	93.3 Percentage of Participants Interval 89.1 to 96.3	48.7 Percentage of Participants Interval 41.6 to 55.9	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 23B	87.4 Percentage of Participants Interval 82.4 to 91.4	40.4 Percentage of Participants Interval 33.9 to 47.0	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 24F	82.8 Percentage of Participants Interval 77.2 to 87.5	15.3 Percentage of Participants Interval 10.6 to 21.0	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 31	86.6 Percentage of Participants Interval 81.3 to 90.8	30.1 Percentage of Participants Interval 24.0 to 36.9	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 35B	73.2 Percentage of Participants Interval 67.0 to 78.9	11.3 Percentage of Participants Interval 7.5 to 16.2	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 6C	58.4 Percentage of Participants Interval 51.8 to 64.9	33.8 Percentage of Participants Interval 27.7 to 40.3	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 15B	71.0 Percentage of Participants Interval 64.6 to 76.8	75.3 Percentage of Participants Interval 69.1 to 80.8	—
Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination Serotype 20B	52.8 Percentage of Participants Interval 46.2 to 59.4	44.1 Percentage of Participants Interval 37.5 to 50.8	—

Adverse Events

Phase 1: V116 0.5 mL

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Phase 1: V116 1.0 mL

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Phase 1: PPSV23

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Phase 2: V116

Serious events: 4 serious events

Other events: 159 other events

Deaths: 1 deaths

Phase 2: PPSV23

Serious events: 3 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: V116 0.5 mL n=30 participants at risk Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 participants at risk Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: PPSV23 n=30 participants at risk Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1	Phase 2: V116 n=254 participants at risk Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2	Phase 2: PPSV23 n=254 participants at risk Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2
Cardiac disorders Acute coronary syndrome	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Cardiac disorders Atrial fibrillation	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Infections and infestations COVID-19	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Infections and infestations Urinary tract infection	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Nervous system disorders Cervical radiculopathy	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.

Other adverse events

Other adverse events
Measure	Phase 1: V116 0.5 mL n=30 participants at risk Participants received a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1	Phase 1: V116 1.0 mL n=30 participants at risk Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 1	Phase 1: PPSV23 n=30 participants at risk Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 1	Phase 2: V116 n=254 participants at risk Participants received a single IM 1.0 mL vaccination on Day 1 of Phase 2	Phase 2: PPSV23 n=254 participants at risk Participants received a single IM 0.5 mL vaccination on Day 1 of Phase 2
General disorders Fatigue	26.7% 8/30 • Number of events 8 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	26.7% 8/30 • Number of events 8 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	16.7% 5/30 • Number of events 5 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	19.7% 50/254 • Number of events 50 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	12.6% 32/254 • Number of events 34 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
General disorders Injection site bruising	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	6.7% 2/30 • Number of events 2 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	3.3% 1/30 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
General disorders Injection site erythema	10.0% 3/30 • Number of events 3 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	23.3% 7/30 • Number of events 7 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	20.0% 6/30 • Number of events 6 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	10.2% 26/254 • Number of events 26 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	6.7% 17/254 • Number of events 17 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
General disorders Injection site pain	73.3% 22/30 • Number of events 23 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	76.7% 23/30 • Number of events 23 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	56.7% 17/30 • Number of events 17 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	46.5% 118/254 • Number of events 119 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	37.8% 96/254 • Number of events 96 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
General disorders Injection site swelling	20.0% 6/30 • Number of events 6 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	16.7% 5/30 • Number of events 5 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	13.3% 4/30 • Number of events 4 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	11.8% 30/254 • Number of events 30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	7.9% 20/254 • Number of events 20 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
General disorders Pyrexia	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	6.7% 2/30 • Number of events 2 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.39% 1/254 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Infections and infestations Upper respiratory tract infection	3.3% 1/30 • Number of events 1 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	6.7% 2/30 • Number of events 2 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/30 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	0.00% 0/254 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 5/30 • Number of events 5 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	10.0% 3/30 • Number of events 3 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	6.7% 2/30 • Number of events 2 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	4.3% 11/254 • Number of events 14 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	4.7% 12/254 • Number of events 13 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Musculoskeletal and connective tissue disorders Myalgia	26.7% 8/30 • Number of events 8 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	30.0% 9/30 • Number of events 9 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	13.3% 4/30 • Number of events 4 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	13.0% 33/254 • Number of events 35 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	10.2% 26/254 • Number of events 28 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.
Nervous system disorders Headache	33.3% 10/30 • Number of events 10 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	20.0% 6/30 • Number of events 6 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	16.7% 5/30 • Number of events 7 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	18.5% 47/254 • Number of events 59 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.	16.1% 41/254 • Number of events 47 • Up to approximately 195 days post-vaccination for Phase 1 and up to approximately 293 days post-vaccination for Phase 2. The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination. AEs were reported for participants separately during the Phase 1 (MedDRA 23.0) and Phase 2 (MedDRA 24.0) parts of the study.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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