Trial Outcomes & Findings for Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) (NCT NCT05425732)
NCT ID: NCT05425732
Last Updated: 2024-10-26
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2663 participants
Primary outcome timeframe
Up to 5 days post-vaccination
Results posted on
2024-10-26
Participant Flow
Pneumococcal vaccine-naïve adults ≥18 years of age were enrolled in this study. Participants with underlying chronic conditions were eligible if the conditions were assessed to be stable per the investigator's judgment.
Participant milestones
| Measure |
Cohort 1 V116
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.
|
Cohort 1 PCV20
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1181
|
1181
|
201
|
100
|
|
Overall Study
Vaccinated
|
1179
|
1177
|
200
|
100
|
|
Overall Study
Safety All Cause Mortality (ACM) Population
|
1179
|
1179
|
201
|
100
|
|
Overall Study
All Participants As Treated (APaT)
|
1177
|
1175
|
200
|
100
|
|
Overall Study
Safety Adverse Event (AE) Population
|
1177
|
1175
|
200
|
100
|
|
Overall Study
COMPLETED
|
1160
|
1152
|
195
|
96
|
|
Overall Study
NOT COMPLETED
|
21
|
29
|
6
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1 V116
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.
|
Cohort 1 PCV20
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Death
|
4
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
15
|
5
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
1
|
1
|
|
Overall Study
Randomized to PCV20 first, discontinued; then randomized to V116 second
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Baseline characteristics by cohort
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
n=100 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
Total
n=2656 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
63.9 Years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
35.2 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
34.6 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
60.7 Years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
|
Age, Customized
18 to 49 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Age, Customized
50 to 64 years
|
589 Participants
n=5 Participants
|
587 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1176 Participants
n=21 Participants
|
|
Age, Customized
65 to 74 years
|
464 Participants
n=5 Participants
|
464 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
928 Participants
n=21 Participants
|
|
Age, Customized
75 to 84 years
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
225 Participants
n=21 Participants
|
|
Age, Customized
≥85 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
687 Participants
n=5 Participants
|
670 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
1558 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
492 Participants
n=5 Participants
|
507 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
1098 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
259 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
583 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
909 Participants
n=5 Participants
|
922 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
2048 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
148 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
369 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
867 Participants
n=5 Participants
|
844 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
1912 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days post-vaccinationPopulation: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Outcome measures
| Measure |
Cohort 1 V116
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1175 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
n=100 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site erythema
|
5.4 Percentage of participants
|
6.3 Percentage of participants
|
15.5 Percentage of participants
|
13.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site pain
|
39.4 Percentage of participants
|
51.7 Percentage of participants
|
71.5 Percentage of participants
|
74.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site swelling
|
6.0 Percentage of participants
|
8.3 Percentage of participants
|
14.0 Percentage of participants
|
14.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 5 days post-vaccinationPopulation: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C)
Outcome measures
| Measure |
Cohort 1 V116
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1175 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
n=100 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs
Fatigue
|
20.1 Percentage of participants
|
19.6 Percentage of participants
|
40.5 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Headache
|
11.5 Percentage of participants
|
12.9 Percentage of participants
|
29.5 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Myalgia
|
5.9 Percentage of participants
|
6.7 Percentage of participants
|
16.5 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Pyrexia
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
3.5 Percentage of participants
|
1.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 194 days post-vaccinationPopulation: All participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event, which is determined by the investigator to be related to the vaccine.
Outcome measures
| Measure |
Cohort 1 V116
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1175 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
n=100 Participants
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Vaccine-related Serious AE (SAE)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
274.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
176.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
2302.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2972.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
3637.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3429.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
2501.3 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1811.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
3893.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4678.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 11A
|
3232.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2092.8 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
2641.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2499.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
2136.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2817.8 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
3874.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4770.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
13558.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
11742.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
7470.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1640.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype15A
|
5237.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1589.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
4216.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2072.3 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
4868.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
846.3 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined..
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
7764.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
460.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
6099.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
631.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
3737.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
461.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
1082.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
107.3 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
2728.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
70.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
3132.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
144.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
8527.8 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1383.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Cohort 2 were not analyzed in this outcome measure.
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 17F
|
75.8 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
9.5 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 20A
|
67.3 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
9.6 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 23A
|
78.9 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
36.8 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 9N
|
64.7 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
19.9 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 15A
|
66.7 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
35.8 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 15C
|
83.4 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
74.2 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 16F
|
71.9 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
20.8 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 23B
|
85.5 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
49.6 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 24F
|
80.5 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
6.3 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 31
|
76.5 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
17.9 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Serotype 35B
|
60.0 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
6.8 Percentage of participants
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=589 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 3
|
308.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
282.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 6A
|
5289.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2572.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 7F
|
6447.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4278.8 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 8
|
4516.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3004.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 9N
|
17283.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
8791.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 10A
|
6808.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4382.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 11A
|
5871.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3785.8 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 12F
|
6150.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3561.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 15A
|
11319.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5901.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 15C
|
10194.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5708.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 16F
|
8877.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5720.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype17F
|
16070.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
10068.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 19A
|
2773.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2374.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 20A
|
13150.0 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
7562.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 22F
|
9299.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4683.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 23A
|
8848.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
4739.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 23B
|
2140.1 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1420.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 24F
|
4137.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3047.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 31
|
8005.6 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
3820.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 33F
|
34805.5 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
17607.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Serotype 35B
|
13933.4 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
9053.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 and V116 Cohort 2 were not analyzed in this outcome measure.
The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \> 50 percentage points (one-sided p-value \< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
Serotype 6C
|
49.3 Percentage of participants
Interval 46.0 to 52.6
|
—
|
—
|
—
|
|
Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
Serotype 15B
|
64.7 Percentage of participants
Interval 61.4 to 67.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 30 post-vaccinationPopulation: All randomized participants treated with V116 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=200 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=589 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2
15B
|
10976.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5438.9 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2
6C
|
2577.2 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1254.7 Titer
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
0.78 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.53 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
4.30 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5.45 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
6.97 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
6.57 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
10.02 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
7.00 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
11.98 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
14.66 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 11A
|
7.20 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5.87 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
1.73 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1.57 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
8.39 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
12.02 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
4.39 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5.48 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
13.81 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
13.02 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined..
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
7.72 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1.43 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype15A
|
13.88 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
2.04 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
12.39 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
5.04 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
2.86 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.33 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
14.16 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.84 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
19.03 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1.47 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
3.78 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.59 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
5.13 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1.58 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
6.87 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.33 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
3.07 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
0.27 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
|
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
19.98 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
1.41 μg/mL
NA: per protocol, within group CIs, or any other measures of dispersion, were not determined.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
8.4 GMFR
Interval 7.7 to 9.1
|
5.4 GMFR
Interval 5.0 to 5.8
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
18.1 GMFR
Interval 16.2 to 20.2
|
22.6 GMFR
Interval 20.1 to 25.5
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
16.5 GMFR
Interval 14.4 to 18.8
|
14.7 GMFR
Interval 12.9 to 16.8
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
22.0 GMFR
Interval 19.3 to 25.0
|
14.2 GMFR
Interval 12.5 to 16.2
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
16.7 GMFR
Interval 14.8 to 18.9
|
20.8 GMFR
Interval 18.3 to 23.8
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype11A
|
17.4 GMFR
Interval 15.1 to 20.0
|
11.6 GMFR
Interval 10.1 to 13.3
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
77.4 GMFR
Interval 68.5 to 87.4
|
73.5 GMFR
Interval 64.8 to 83.4
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
8.6 GMFR
Interval 7.7 to 9.5
|
11.0 GMFR
Interval 9.9 to 12.2
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
19.1 GMFR
Interval 16.6 to 22.1
|
25.5 GMFR
Interval 21.9 to 29.8
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
9.9 GMFR
Interval 8.9 to 11.1
|
8.5 GMFR
Interval 7.6 to 9.5
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
8.9 GMFR
Interval 8.0 to 9.9
|
2.0 GMFR
Interval 1.9 to 2.2
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15A
|
9.4 GMFR
Interval 8.2 to 10.8
|
3.1 GMFR
Interval 2.7 to 3.5
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
38.0 GMFR
Interval 33.3 to 43.3
|
20.3 GMFR
Interval 17.8 to 23.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
9.5 GMFR
Interval 8.7 to 10.4
|
1.9 GMFR
Interval 1.7 to 2.0
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
17.3 GMFR
Interval 15.3 to 19.7
|
1.2 GMFR
Interval 1.1 to 1.3
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
10.3 GMFR
Interval 9.2 to 11.4
|
1.2 GMFR
Interval 1.1 to 1.2
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
21.8 GMFR
Interval 19.0 to 25.0
|
3.1 GMFR
Interval 2.7 to 3.6
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
51.4 GMFR
Interval 45.3 to 58.2
|
6.1 GMFR
Interval 5.4 to 6.9
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
29.0 GMFR
Interval 25.6 to 32.8
|
1.1 GMFR
Interval 1.0 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
28.7 GMFR
Interval 24.9 to 33.1
|
1.5 GMFR
Interval 1.4 to 1.7
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
7.2 GMFR
Interval 6.5 to 7.9
|
1.2 GMFR
Interval 1.1 to 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
5.1 GMFR
Interval 4.8 to 5.4
|
3.5 GMFR
Interval 3.3 to 3.7
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
12.2 GMFR
Interval 11.1 to 13.5
|
15.1 GMFR
Interval 13.8 to 16.6
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
12.5 GMFR
Interval 11.5 to 13.7
|
12.2 GMFR
Interval 11.2 to 13.4
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
12.6 GMFR
Interval 11.5 to 13.8
|
8.8 GMFR
Interval 8.0 to 9.6
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
15.4 GMFR
Interval 14.1 to 16.9
|
19.2 GMFR
Interval 17.4 to 21.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype11A
|
8.7 GMFR
Interval 8.1 to 9.5
|
7.1 GMFR
Interval 6.5 to 7.7
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
13.1 GMFR
Interval 11.8 to 14.4
|
12.1 GMFR
Interval 11.0 to 13.5
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
5.4 GMFR
Interval 5.0 to 5.8
|
7.7 GMFR
Interval 7.1 to 8.4
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
12.7 GMFR
Interval 11.6 to 13.9
|
16.3 GMFR
Interval 14.8 to 17.9
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
9.6 GMFR
Interval 8.8 to 10.5
|
9.1 GMFR
Interval 8.3 to 9.9
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
15.0 GMFR
Interval 13.6 to 16.5
|
2.7 GMFR
Interval 2.5 to 2.9
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15A
|
22.3 GMFR
Interval 20.3 to 24.4
|
3.4 GMFR
Interval 3.1 to 3.7
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
19.8 GMFR
Interval 17.9 to 21.8
|
8.2 GMFR
Interval 7.4 to 9.0
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
13.3 GMFR
Interval 12.3 to 14.4
|
1.6 GMFR
Interval 1.5 to 1.7
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
19.8 GMFR
Interval 18.0 to 21.7
|
1.2 GMFR
Interval 1.1 to 1.3
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
11.7 GMFR
Interval 10.8 to 12.8
|
0.9 GMFR
Interval 0.9 to 1.0
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
17.8 GMFR
Interval 16.3 to 19.5
|
2.9 GMFR
Interval 2.6 to 3.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
12.1 GMFR
Interval 11.1 to 13.3
|
3.8 GMFR
Interval 3.5 to 4.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
21.2 GMFR
Interval 19.3 to 23.4
|
1.1 GMFR
Interval 1.0 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
13.0 GMFR
Interval 12.0 to 14.0
|
1.2 GMFR
Interval 1.2 to 1.3
|
—
|
—
|
|
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
14.7 GMFR
Interval 13.6 to 16.0
|
1.0 GMFR
Interval 1.0 to 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
56.5 Percentage of participants
Interval 53.5 to 59.4
|
41.0 Percentage of participants
Interval 38.0 to 44.0
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
73.1 Percentage of participants
Interval 70.4 to 75.7
|
79.7 Percentage of participants
Interval 77.2 to 82.1
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
76.4 Percentage of participants
Interval 73.8 to 78.9
|
75.8 Percentage of participants
Interval 73.2 to 78.4
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
75.8 Percentage of participants
Interval 73.1 to 78.3
|
67.8 Percentage of participants
Interval 64.9 to 70.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
80.3 Percentage of participants
Interval 77.8 to 82.6
|
82.0 Percentage of participants
Interval 79.5 to 84.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype11A
|
71.1 Percentage of participants
Interval 68.4 to 73.8
|
62.7 Percentage of participants
Interval 59.8 to 65.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
74.2 Percentage of participants
Interval 71.5 to 76.7
|
71.4 Percentage of participants
Interval 68.6 to 74.1
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
55.6 Percentage of participants
Interval 52.6 to 58.5
|
65.0 Percentage of participants
Interval 62.0 to 67.8
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
76.8 Percentage of participants
Interval 74.2 to 79.3
|
78.5 Percentage of participants
Interval 76.0 to 81.0
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
71.6 Percentage of participants
Interval 68.8 to 74.2
|
66.7 Percentage of participants
Interval 63.8 to 69.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
77.9 Percentage of participants
Interval 75.3 to 80.3
|
29.4 Percentage of participants
Interval 26.7 to 32.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15A
|
85.7 Percentage of participants
Interval 83.5 to 87.8
|
37.7 Percentage of participants
Interval 34.8 to 40.7
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
81.4 Percentage of participants
Interval 78.9 to 83.6
|
63.2 Percentage of participants
Interval 60.2 to 66.1
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
81.4 Percentage of participants
Interval 78.9 to 83.6
|
11.8 Percentage of participants
Interval 10.0 to 13.9
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
84.5 Percentage of participants
Interval 82.2 to 86.6
|
4.3 Percentage of participants
Interval 3.1 to 5.7
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
74.7 Percentage of participants
Interval 72.1 to 77.3
|
1.3 Percentage of participants
Interval 0.7 to 2.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
85.5 Percentage of participants
Interval 83.3 to 87.6
|
29.4 Percentage of participants
Interval 26.7 to 32.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
76.1 Percentage of participants
Interval 73.4 to 78.6
|
42.2 Percentage of participants
Interval 39.3 to 45.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
84.0 Percentage of participants
Interval 81.7 to 86.1
|
2.3 Percentage of participants
Interval 1.5 to 3.4
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
81.1 Percentage of participants
Interval 78.6 to 83.4
|
3.9 Percentage of participants
Interval 2.8 to 5.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
83.1 Percentage of participants
Interval 80.8 to 85.3
|
3.3 Percentage of participants
Interval 2.3 to 4.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 30 post-vaccinationPopulation: All randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Outcome measures
| Measure |
Cohort 1 V116
n=1179 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1 PCV20
n=1177 Participants
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 3
|
71.3 Percentage of participants
Interval 68.4 to 74.2
|
59.1 Percentage of participants
Interval 55.9 to 62.3
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 6A
|
76.8 Percentage of participants
Interval 74.0 to 79.5
|
79.9 Percentage of participants
Interval 77.2 to 82.4
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 7F
|
71.0 Percentage of participants
Interval 68.1 to 73.9
|
65.9 Percentage of participants
Interval 62.8 to 68.9
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 8
|
75.8 Percentage of participants
Interval 73.0 to 78.4
|
67.4 Percentage of participants
Interval 64.3 to 70.3
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 10A
|
71.9 Percentage of participants
Interval 69.0 to 74.6
|
74.1 Percentage of participants
Interval 71.3 to 76.9
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype11A
|
70.0 Percentage of participants
Interval 66.9 to 73.0
|
61.5 Percentage of participants
Interval 58.2 to 64.7
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 12F
|
89.0 Percentage of participants
Interval 87.0 to 90.9
|
87.1 Percentage of participants
Interval 84.9 to 89.1
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 19A
|
64.4 Percentage of participants
Interval 61.3 to 67.3
|
70.2 Percentage of participants
Interval 67.2 to 73.0
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 22F
|
70.5 Percentage of participants
Interval 67.5 to 73.4
|
74.4 Percentage of participants
Interval 71.5 to 77.2
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 33F
|
67.7 Percentage of participants
Interval 64.6 to 70.7
|
61.5 Percentage of participants
Interval 58.3 to 64.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 9N
|
64.7 Percentage of participants
Interval 61.5 to 67.8
|
19.9 Percentage of participants
Interval 17.5 to 22.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15A
|
66.7 Percentage of participants
Interval 63.0 to 70.2
|
35.8 Percentage of participants
Interval 32.3 to 39.5
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 15C
|
83.4 Percentage of participants
Interval 80.9 to 85.7
|
74.2 Percentage of participants
Interval 71.2 to 76.9
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 16F
|
71.9 Percentage of participants
Interval 68.8 to 74.8
|
20.8 Percentage of participants
Interval 18.3 to 23.5
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 17F
|
75.8 Percentage of participants
Interval 72.7 to 78.6
|
9.5 Percentage of participants
Interval 7.7 to 11.5
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 20A
|
67.3 Percentage of participants
Interval 64.3 to 70.2
|
9.6 Percentage of participants
Interval 7.8 to 11.6
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23A
|
78.9 Percentage of participants
Interval 75.8 to 81.7
|
36.8 Percentage of participants
Interval 33.3 to 40.4
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 23B
|
85.5 Percentage of participants
Interval 83.2 to 87.6
|
49.6 Percentage of participants
Interval 46.4 to 52.7
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 24F
|
80.5 Percentage of participants
Interval 77.8 to 83.0
|
6.3 Percentage of participants
Interval 4.8 to 8.1
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 31
|
76.5 Percentage of participants
Interval 73.6 to 79.3
|
17.9 Percentage of participants
Interval 15.5 to 20.5
|
—
|
—
|
|
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Serotype 35B
|
60.0 Percentage of participants
Interval 56.7 to 63.2
|
6.8 Percentage of participants
Interval 5.3 to 8.5
|
—
|
—
|
Adverse Events
Cohort 1: V116
Serious events: 19 serious events
Other events: 615 other events
Deaths: 4 deaths
Cohort 1: PCV20
Serious events: 24 serious events
Other events: 722 other events
Deaths: 2 deaths
Cohort 2: V116
Serious events: 1 serious events
Other events: 161 other events
Deaths: 0 deaths
Cohort 2: PCV20
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Unplanned Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: V116
n=1177 participants at risk
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1: PCV20
n=1175 participants at risk
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2: V116
n=200 participants at risk
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2: PCV20
n=100 participants at risk
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
Unplanned Participants
n=2 participants at risk
Participants with unplanned randomization and unplanned treatment with both V116 and PCV20.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Cardiac disorders
Coronary artery embolism
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.34%
4/1175 • Number of events 4 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
1.0%
1/100 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Hepatobiliary disorders
Subcapsular hepatic haematoma
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Abdominal wall abscess
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
1.0%
1/100 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Peritonitis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Pneumonia aspiration
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Sepsis
|
0.17%
2/1177 • Number of events 2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Septic shock
|
0.08%
1/1177 • Number of events 2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.50%
1/200 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
1.0%
1/100 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
2/1177 • Number of events 2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Dizziness
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Product Issues
Device occlusion
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Psychiatric disorders
Alcoholism
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Psychiatric disorders
Delirium tremens
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1177 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.09%
1/1175 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1177 • Number of events 1 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/1175 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/200 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/100 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
Other adverse events
| Measure |
Cohort 1: V116
n=1177 participants at risk
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
|
Cohort 1: PCV20
n=1175 participants at risk
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
|
Cohort 2: V116
n=200 participants at risk
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
|
Cohort 2: PCV20
n=100 participants at risk
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
|
Unplanned Participants
n=2 participants at risk
Participants with unplanned randomization and unplanned treatment with both V116 and PCV20.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
20.4%
240/1177 • Number of events 243 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
20.0%
235/1175 • Number of events 237 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
40.5%
81/200 • Number of events 81 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
34.0%
34/100 • Number of events 34 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
General disorders
Injection site erythema
|
7.0%
82/1177 • Number of events 83 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
7.3%
86/1175 • Number of events 87 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
16.0%
32/200 • Number of events 32 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
13.0%
13/100 • Number of events 13 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
General disorders
Injection site pain
|
40.0%
471/1177 • Number of events 474 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
51.7%
608/1175 • Number of events 615 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
71.5%
143/200 • Number of events 143 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
74.0%
74/100 • Number of events 74 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
General disorders
Injection site swelling
|
6.7%
79/1177 • Number of events 79 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
8.8%
103/1175 • Number of events 105 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
14.0%
28/200 • Number of events 28 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
14.0%
14/100 • Number of events 14 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
75/1177 • Number of events 75 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
7.0%
82/1175 • Number of events 83 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
16.5%
33/200 • Number of events 33 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
14.0%
14/100 • Number of events 14 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
|
Nervous system disorders
Headache
|
13.8%
162/1177 • Number of events 176 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
14.8%
174/1175 • Number of events 184 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
29.5%
59/200 • Number of events 62 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
26.0%
26/100 • Number of events 29 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
0.00%
0/2 • All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
ACM population for Cohorts 1 and 2 arms consisted of planned randomized participants, ACM population for the Unplanned Participants consisted of participants randomized to both V116 and PCV20. The SAE and NSAE population for Cohorts 1 and 2 aconsisted of APaT. The SAE and NSAE population for the Unplanned Participants arm consisted of participants excluded from the APaT. Participants with ACM or AEs in from the Unplanned arm were reported as zero due to the risk of identification..
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER