Trial Outcomes & Findings for Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) (NCT NCT05393037)
NCT ID: NCT05393037
Last Updated: 2026-02-05
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
313 participants
Primary outcome timeframe
Up to 5 days after each vaccination in Part A
Results posted on
2026-02-05
Participant Flow
This study is conducted in two parts. Part A evaluated V116 and the comparator regimen of PCV15 followed by PPSV23. Part B evaluated PCV15 in participants who received V116 in Part A.
Participant milestones
| Measure |
V116 + Placebo (Part A), PCV15 (Part B)
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.
|
PCV15 + PPSV23 (Part A)
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
|
|---|---|---|
|
Part A
STARTED
|
156
|
157
|
|
Part A
Vaccination 1- V116
|
155
|
0
|
|
Part A
Vaccination 1- PCV15
|
1
|
156
|
|
Part A
Vaccination 2- Placebo
|
154
|
0
|
|
Part A
Vaccination 2-PCV15
|
0
|
1
|
|
Part A
Vaccination 2-PPSV23
|
0
|
151
|
|
Part A
COMPLETED
|
152
|
152
|
|
Part A
NOT COMPLETED
|
4
|
5
|
|
Part B
STARTED
|
126
|
0
|
|
Part B
COMPLETED
|
125
|
0
|
|
Part B
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
V116 + Placebo (Part A), PCV15 (Part B)
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.
|
PCV15 + PPSV23 (Part A)
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
|
|---|---|---|
|
Part A
Death
|
1
|
0
|
|
Part A
Lost to Follow-up
|
1
|
1
|
|
Part A
Withdrawal by Subject
|
2
|
4
|
|
Part B
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)
Baseline characteristics by cohort
| Measure |
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.
|
PCV15 + PPSV23 (Part A)
n=157 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 Years
STANDARD_DEVIATION 12.6 • n=41 Participants
|
46.7 Years
STANDARD_DEVIATION 12.3 • n=1581 Participants
|
45.3 Years
STANDARD_DEVIATION 12.5 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=41 Participants
|
50 Participants
n=1581 Participants
|
92 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=41 Participants
|
107 Participants
n=1581 Participants
|
221 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=41 Participants
|
44 Participants
n=1581 Participants
|
76 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=41 Participants
|
112 Participants
n=1581 Participants
|
236 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
33 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=41 Participants
|
63 Participants
n=1581 Participants
|
125 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=41 Participants
|
79 Participants
n=1581 Participants
|
149 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after each vaccination in Part APopulation: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=155 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=155 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A
Injection site erythema
|
11.0 Percentage of Participants
Interval 6.5 to 17.0
|
3.9 Percentage of Participants
Interval 1.4 to 8.2
|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A
Injection site pain
|
82.6 Percentage of Participants
Interval 75.7 to 88.2
|
50.3 Percentage of Participants
Interval 42.2 to 58.4
|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 Through Day 5 Postvaccination in Part A
Injection site swelling
|
20.6 Percentage of Participants
Interval 14.6 to 27.9
|
7.1 Percentage of Participants
Interval 3.6 to 12.3
|
PRIMARY outcome
Timeframe: Up to 5 days after each vaccination in Part APopulation: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=155 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=155 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
Fatigue
|
34.2 Percentage of Participants
Interval 26.8 to 42.2
|
30.3 Percentage of Participants
Interval 23.2 to 38.2
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
Headache
|
19.4 Percentage of Participants
Interval 13.5 to 26.5
|
21.9 Percentage of Participants
Interval 15.7 to 29.3
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
Myalgia
|
15.5 Percentage of Participants
Interval 10.2 to 22.2
|
12.3 Percentage of Participants
Interval 7.5 to 18.5
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 Through Day 5 Postvaccination in Part A
Pyrexia
|
3.2 Percentage of Participants
Interval 1.1 to 7.4
|
1.9 Percentage of Participants
Interval 0.4 to 5.6
|
PRIMARY outcome
Timeframe: Up to 194 days in Part APopulation: All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=155 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=155 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through the Duration of Participation in Part A
|
0.0 Percentage of Participants
Interval 0.0 to 2.4
|
0.0 Percentage of Participants
Interval 0.0 to 2.4
|
PRIMARY outcome
Timeframe: Up to 114 daysPopulation: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
172.0 Titers
Interval 138.4 to 213.7
|
170.7 Titers
Interval 132.5 to 220.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
3979.5 Titers
Interval 3210.6 to 4932.5
|
3896.0 Titers
Interval 2929.7 to 5181.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
3275.6 Titers
Interval 2658.1 to 4036.6
|
3482.3 Titers
Interval 2815.8 to 4306.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
2262.9 Titers
Interval 1776.5 to 2882.5
|
1847.5 Titers
Interval 1470.9 to 2320.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
5970.0 Titers
Interval 4786.9 to 7445.6
|
5763.0 Titers
Interval 4552.8 to 7294.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
3652.8 Titers
Interval 2731.4 to 4885.1
|
3693.0 Titers
Interval 2870.2 to 4751.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
1722.3 Titers
Interval 1277.1 to 2322.7
|
3742.5 Titers
Interval 3050.7 to 4591.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
2292.4 Titers
Interval 1653.2 to 3178.8
|
2585.4 Titers
Interval 1993.5 to 3353.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
5886.3 Titers
Interval 4489.8 to 7717.1
|
8698.6 Titers
Interval 7046.1 to 10738.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
2667.0 Titers
Interval 2193.2 to 3243.1
|
2178.9 Titers
Interval 1777.1 to 2671.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
5753.3 Titers
Interval 4634.0 to 7143.0
|
7249.1 Titers
Interval 5854.9 to 8975.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F (Shared)
|
3979.8 Titers
Interval 3214.5 to 4927.1
|
3622.4 Titers
Interval 2902.8 to 4520.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
11864.5 Titers
Interval 9283.8 to 15162.5
|
14642.5 Titers
Interval 11314.9 to 18948.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (Unique to V116)
|
1970.5 Titers
Interval 1555.1 to 2496.8
|
5859.0 Titers
Interval 4684.9 to 7327.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (Unique to V116)
|
2438.0 Titers
Interval 1791.5 to 3317.7
|
5613.0 Titers
Interval 4136.7 to 7616.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (Unique to V116)
|
1839.0 Titers
Interval 1474.3 to 2293.9
|
6703.0 Titers
Interval 5494.0 to 8178.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23A (Unique to V116)
|
1674.9 Titers
Interval 1209.9 to 2318.7
|
5053.5 Titers
Interval 3781.3 to 6753.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (Unique to V116)
|
151.0 Titers
Interval 98.1 to 232.6
|
1593.8 Titers
Interval 1182.7 to 2147.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24B (Unique to V116)
|
567.9 Titers
Interval 375.4 to 859.1
|
3725.6 Titers
Interval 3161.1 to 4391.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (Unique to V116)
|
530.8 Titers
Interval 364.2 to 773.7
|
5699.4 Titers
Interval 4435.1 to 7324.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (Unique to V116)
|
2977.7 Titers
Interval 2425.5 to 3655.8
|
11306.2 Titers
Interval 9364.7 to 13650.1
|
SECONDARY outcome
Timeframe: Up to 114 daysPopulation: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23F (Unique to V116)
|
0.41 μg/mL
Interval 0.3 to 0.55
|
2.54 μg/mL
Interval 1.85 to 3.5
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
3.73 μg/mL
Interval 2.78 to 5.0
|
7.15 μg/mL
Interval 5.24 to 9.75
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
2.64 μg/mL
Interval 2.13 to 3.27
|
4.40 μg/mL
Interval 3.55 to 5.45
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
0.58 μg/mL
Interval 0.49 to 0.67
|
0.50 μg/mL
Interval 0.43 to 0.59
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
2.80 μg/mL
Interval 2.02 to 3.89
|
3.79 μg/mL
Interval 2.77 to 5.18
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
1.81 μg/mL
Interval 1.49 to 2.21
|
2.95 μg/mL
Interval 2.31 to 3.77
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
8.10 μg/mL
Interval 6.66 to 9.85
|
7.05 μg/mL
Interval 5.76 to 8.64
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
3.36 μg/mL
Interval 2.73 to 4.14
|
5.02 μg/mL
Interval 4.01 to 6.28
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
0.71 μg/mL
Interval 0.51 to 0.99
|
1.10 μg/mL
Interval 0.83 to 1.47
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
4.43 μg/mL
Interval 3.49 to 5.61
|
10.34 μg/mL
Interval 8.24 to 12.96
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
5.99 μg/mL
Interval 4.83 to 7.43
|
5.96 μg/mL
Interval 4.88 to 7.3
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
4.94 μg/mL
Interval 3.81 to 6.41
|
7.08 μg/mL
Interval 5.6 to 8.95
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F (Shared)
|
2.99 μg/mL
Interval 2.4 to 3.72
|
3.70 μg/mL
Interval 2.96 to 4.61
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
5.56 μg/mL
Interval 4.41 to 7.01
|
7.55 μg/mL
Interval 5.9 to 9.65
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (Unique to V116)
|
1.02 μg/mL
Interval 0.8 to 1.31
|
5.67 μg/mL
Interval 4.37 to 7.36
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (Unique to V116)
|
2.68 μg/mL
Interval 2.07 to 3.49
|
6.92 μg/mL
Interval 5.15 to 9.29
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (Unique to V116)
|
0.21 μg/mL
Interval 0.16 to 0.26
|
1.55 μg/mL
Interval 1.23 to 1.95
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (Unique to V116)
|
0.99 μg/mL
Interval 0.75 to 1.31
|
3.27 μg/mL
Interval 2.51 to 4.25
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24F (Unique to V116)
|
0.17 μg/mL
Interval 0.13 to 0.21
|
1.80 μg/mL
Interval 1.25 to 2.59
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (Unique to V116)
|
0.25 μg/mL
Interval 0.2 to 0.31
|
2.20 μg/mL
Interval 1.78 to 2.72
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (Unique to V116)
|
0.90 μg/mL
Interval 0.73 to 1.1
|
10.26 μg/mL
Interval 7.96 to 13.22
|
SECONDARY outcome
Timeframe: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
5.3 Ratio
Interval 4.3 to 6.7
|
5.5 Ratio
Interval 4.3 to 7.1
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
15.3 Ratio
Interval 11.3 to 20.7
|
14.3 Ratio
Interval 10.3 to 19.9
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
7.4 Ratio
Interval 5.4 to 10.3
|
12.3 Ratio
Interval 9.1 to 16.3
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
15.0 Ratio
Interval 10.4 to 21.8
|
11.9 Ratio
Interval 8.6 to 16.3
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
5.9 Ratio
Interval 4.5 to 7.7
|
6.7 Ratio
Interval 5.0 to 8.9
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
7.4 Ratio
Interval 5.4 to 10.2
|
9.4 Ratio
Interval 7.1 to 12.6
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
3.8 Ratio
Interval 2.7 to 5.3
|
9.2 Ratio
Interval 6.4 to 13.4
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
46.7 Ratio
Interval 31.4 to 69.4
|
57.3 Ratio
Interval 42.0 to 78.0
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
8.5 Ratio
Interval 6.4 to 11.5
|
15.1 Ratio
Interval 11.2 to 20.2
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
5.6 Ratio
Interval 4.4 to 7.2
|
5.0 Ratio
Interval 3.9 to 6.3
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
4.7 Ratio
Interval 3.7 to 6.0
|
7.1 Ratio
Interval 5.5 to 9.2
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F(Shared)
|
19.3 Ratio
Interval 12.7 to 29.4
|
19.2 Ratio
Interval 13.2 to 28.1
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
6.8 Ratio
Interval 5.2 to 9.1
|
7.5 Ratio
Interval 5.6 to 10.1
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (Unique to V116)
|
1.4 Ratio
Interval 1.1 to 1.8
|
5.7 Ratio
Interval 4.2 to 7.7
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (Unique to V116)
|
16.3 Ratio
Interval 10.9 to 24.3
|
27.8 Ratio
Interval 18.7 to 41.4
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (Unique to V116)
|
1.7 Ratio
Interval 1.4 to 2.0
|
6.3 Ratio
Interval 4.8 to 8.2
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23A (Unique to V116)
|
2.8 Ratio
Interval 1.7 to 4.8
|
9.0 Ratio
Interval 6.0 to 13.7
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (Unique to V116)
|
7.2 Ratio
Interval 4.9 to 10.4
|
52.0 Ratio
Interval 35.7 to 75.6
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24F (Unique to V116)
|
1.0 Ratio
Interval 0.8 to 1.3
|
5.8 Ratio
Interval 4.0 to 8.3
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (Unique to V116)
|
1.5 Ratio
Interval 1.1 to 2.0
|
19.9 Ratio
Interval 13.8 to 28.6
|
|
Serotype-specific OPA Geometric Mean Fold Rises (GMFRs) Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (Unique to V116)
|
1.3 Ratio
Interval 1.1 to 1.5
|
5.4 Ratio
Interval 4.3 to 6.8
|
SECONDARY outcome
Timeframe: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
4.0 Ratio
Interval 3.4 to 4.6
|
3.7 Ratio
Interval 3.2 to 4.3
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
9.2 Ratio
Interval 7.1 to 11.8
|
11.4 Ratio
Interval 8.8 to 14.6
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
5.7 Ratio
Interval 4.7 to 6.8
|
9.1 Ratio
Interval 7.3 to 11.3
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
10.0 Ratio
Interval 7.9 to 12.8
|
8.1 Ratio
Interval 6.5 to 10.1
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
7.8 Ratio
Interval 6.3 to 9.6
|
10.4 Ratio
Interval 8.3 to 13.0
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
8.2 Ratio
Interval 6.7 to 10.0
|
12.2 Ratio
Interval 9.7 to 15.3
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
4.5 Ratio
Interval 3.8 to 5.3
|
6.6 Ratio
Interval 5.5 to 7.9
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
6.7 Ratio
Interval 5.1 to 8.8
|
9.7 Ratio
Interval 7.7 to 12.4
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
7.5 Ratio
Interval 6.2 to 9.1
|
13.8 Ratio
Interval 11.1 to 17.1
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
4.8 Ratio
Interval 4.1 to 5.6
|
3.8 Ratio
Interval 3.2 to 4.6
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
5.4 Ratio
Interval 4.5 to 6.5
|
7.3 Ratio
Interval 6.0 to 8.9
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F (Shared)
|
10.4 Ratio
Interval 8.4 to 13.0
|
13.7 Ratio
Interval 10.7 to 17.5
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
5.9 Ratio
Interval 4.9 to 7.1
|
8.1 Ratio
Interval 6.6 to 10.0
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (unique to V116)
|
2.4 Ratio
Interval 2.1 to 2.8
|
16.1 Ratio
Interval 13.1 to 19.9
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (unique to V116)
|
6.1 Ratio
Interval 5.0 to 7.5
|
16.6 Ratio
Interval 13.3 to 20.8
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (unique to V116)
|
1.4 Ratio
Interval 1.3 to 1.6
|
8.8 Ratio
Interval 7.3 to 10.7
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23A (unique to V116)
|
2.8 Ratio
Interval 2.3 to 3.4
|
15.8 Ratio
Interval 12.3 to 20.3
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (unique to V116)
|
3.6 Ratio
Interval 2.9 to 4.4
|
10.0 Ratio
Interval 8.0 to 12.6
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24F (unique to V116)
|
1.0 Ratio
Interval 0.9 to 1.1
|
10.9 Ratio
Interval 8.3 to 14.2
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (unique to V116)
|
1.4 Ratio
Interval 1.3 to 1.6
|
11.6 Ratio
Interval 9.6 to 14.0
|
|
Serotype-specific IgG GMFRs Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (unique to V116)
|
1.1 Ratio
Interval 1.0 to 1.1
|
11.8 Ratio
Interval 9.4 to 14.7
|
SECONDARY outcome
Timeframe: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
61.9 Percentage of Participants
Interval 52.5 to 70.6
|
58.7 Percentage of Participants
Interval 49.4 to 67.6
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
80.2 Percentage of Participants
Interval 71.7 to 87.0
|
73.8 Percentage of Participants
Interval 65.0 to 81.3
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
59.2 Percentage of Participants
Interval 49.8 to 68.0
|
69.0 Percentage of Participants
Interval 60.3 to 76.8
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
70.1 Percentage of Participants
Interval 61.3 to 77.9
|
66.9 Percentage of Participants
Interval 58.3 to 74.7
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
57.7 Percentage of Participants
Interval 48.5 to 66.6
|
56.3 Percentage of Participants
Interval 47.2 to 65.2
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
60.5 Percentage of Participants
Interval 50.9 to 69.6
|
62.2 Percentage of Participants
Interval 53.2 to 70.7
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
43.6 Percentage of Participants
Interval 34.4 to 53.1
|
53.6 Percentage of Participants
Interval 44.5 to 62.6
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
83.3 Percentage of Participants
Interval 75.4 to 89.5
|
92.2 Percentage of Participants
Interval 86.1 to 96.2
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
64.7 Percentage of Participants
Interval 55.4 to 73.2
|
77.1 Percentage of Participants
Interval 68.9 to 84.0
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
55.9 Percentage of Participants
Interval 46.8 to 64.7
|
49.2 Percentage of Participants
Interval 40.4 to 58.1
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
49.2 Percentage of Participants
Interval 40.1 to 58.3
|
59.2 Percentage of Participants
Interval 50.3 to 67.8
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F (Shared)
|
71.7 Percentage of Participants
Interval 62.4 to 79.8
|
76.0 Percentage of Participants
Interval 67.4 to 83.3
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
58.8 Percentage of Participants
Interval 49.4 to 67.8
|
61.9 Percentage of Participants
Interval 52.3 to 70.9
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (Unique to V116)
|
21.1 Percentage of Participants
Interval 14.0 to 29.7
|
59.3 Percentage of Participants
Interval 49.4 to 68.6
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (Unique to V116)
|
16.8 Percentage of Participants
Interval 10.6 to 24.8
|
53.6 Percentage of Participants
Interval 44.5 to 62.6
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23A (Unique to V116)
|
32.5 Percentage of Participants
Interval 22.2 to 44.1
|
57.9 Percentage of Participants
Interval 47.3 to 68.0
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (Unique to V116)
|
50.0 Percentage of Participants
Interval 40.7 to 59.3
|
87.0 Percentage of Participants
Interval 79.7 to 92.4
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24F (Unique to V116)
|
7.2 Percentage of Participants
Interval 2.4 to 16.1
|
53.8 Percentage of Participants
Interval 43.1 to 64.4
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (Unique to V116)
|
16.5 Percentage of Participants
Interval 10.4 to 24.4
|
73.7 Percentage of Participants
Interval 65.3 to 80.9
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (Unique to V116)
|
5.6 Percentage of Participants
Interval 2.3 to 11.2
|
55.6 Percentage of Participants
Interval 46.8 to 64.2
|
|
Percentage of Participants With a >=4-fold Rise in OPA Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (Unique to V116)
|
71.0 Percentage of Participants
Interval 61.5 to 79.4
|
80.4 Percentage of Participants
Interval 71.8 to 87.3
|
SECONDARY outcome
Timeframe: Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)Population: Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
n=156 Participants
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=156 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 3 (Shared)
|
50.4 Percentage of participants
Interval 41.6 to 59.2
|
42.3 Percentage of participants
Interval 33.9 to 51.1
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 6A (Shared)
|
68.2 Percentage of participants
Interval 59.5 to 76.0
|
70.8 Percentage of participants
Interval 62.4 to 78.3
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 7F (Shared)
|
57.9 Percentage of participants
Interval 49.0 to 66.4
|
70.1 Percentage of participants
Interval 61.7 to 77.6
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 8 (Shared)
|
73.7 Percentage of participants
Interval 65.3 to 80.9
|
66.4 Percentage of participants
Interval 57.9 to 74.3
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 9N (Shared)
|
67.7 Percentage of participants
Interval 59.0 to 75.5
|
75.2 Percentage of participants
Interval 67.1 to 82.2
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 10A (Shared)
|
68.4 Percentage of participants
Interval 59.8 to 76.2
|
76.6 Percentage of participants
Interval 68.7 to 83.4
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 11A (Shared)
|
54.1 Percentage of participants
Interval 45.3 to 62.8
|
66.4 Percentage of participants
Interval 57.9 to 74.3
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 12F (Shared)
|
60.2 Percentage of participants
Interval 51.3 to 68.5
|
67.9 Percentage of participants
Interval 59.4 to 75.6
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 17F (Shared)
|
73.7 Percentage of participants
Interval 65.3 to 80.9
|
83.9 Percentage of participants
Interval 76.7 to 89.7
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 19A (Shared)
|
58.6 Percentage of participants
Interval 49.8 to 67.1
|
43.8 Percentage of participants
Interval 35.3 to 52.5
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 20A (Shared)
|
57.1 Percentage of participants
Interval 48.3 to 65.7
|
67.2 Percentage of participants
Interval 58.6 to 74.9
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 22F (Shared)
|
78.9 Percentage of participants
Interval 71.0 to 85.5
|
76.6 Percentage of participants
Interval 68.7 to 83.4
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 33F (Shared)
|
63.2 Percentage of participants
Interval 54.4 to 71.4
|
67.9 Percentage of participants
Interval 59.4 to 75.6
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15A (Unique to V116)
|
21.8 Percentage of participants
Interval 15.1 to 29.8
|
83.9 Percentage of participants
Interval 76.7 to 89.7
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 15C (Unique to V116)
|
61.7 Percentage of participants
Interval 52.8 to 69.9
|
82.5 Percentage of participants
Interval 75.1 to 88.4
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 16F (Unique to V116)
|
9.0 Percentage of participants
Interval 4.7 to 15.2
|
73.7 Percentage of participants
Interval 65.5 to 80.9
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23A (Unique to V116)
|
29.3 Percentage of participants
Interval 21.8 to 37.8
|
82.5 Percentage of participants
Interval 75.1 to 88.4
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 23B (Unique to V116)
|
37.6 Percentage of participants
Interval 29.3 to 46.4
|
72.3 Percentage of participants
Interval 64.0 to 79.6
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 24F (Unique to V116)
|
0.0 Percentage of participants
Interval 0.0 to 2.7
|
70.1 Percentage of participants
Interval 61.7 to 77.6
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 31 (Unique to V116)
|
6.8 Percentage of participants
Interval 3.1 to 12.5
|
83.2 Percentage of participants
Interval 75.9 to 89.0
|
|
Percentage of Participants With a >=4-fold Rise in IgG Responses From Baseline (Day 1) to Postvaccination in Part A for 13 Serotypes Common Between V116 and PCV15 + PPSV23 and 8 Serotypes Unique to V116
Serotype 35B (Unique to V116)
|
0.8 Percentage of participants
Interval 0.0 to 4.1
|
75.9 Percentage of participants
Interval 67.9 to 82.8
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccination in Part BPopulation: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B.
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=126 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Injection site erythema
|
—
|
3.2 Percentage of Participants
Interval 0.9 to 7.9
|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Injection site pain
|
—
|
61.9 Percentage of Participants
Interval 52.8 to 70.4
|
|
Percentage of Participants With Solicited Injection-site AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Injection site swelling
|
—
|
6.3 Percentage of Participants
Interval 2.8 to 12.1
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccination in Part BPopulation: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=126 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Fatigue
|
—
|
22.2 Percentage of Participants
Interval 15.3 to 30.5
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Headache
|
—
|
14.3 Percentage of Participants
Interval 8.7 to 21.6
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Myalgia
|
—
|
11.1 Percentage of Participants
Interval 6.2 to 17.9
|
|
Percentage of Participants With Solicited Systemic AEs From Day 1 of Part B Through Day 5 Postvaccination in Part B
Pyrexia
|
—
|
0.8 Percentage of Participants
Interval 0.0 to 4.3
|
SECONDARY outcome
Timeframe: Up to 44 days after vaccination in Part BPopulation: All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
Outcome measures
| Measure |
PCV15 + PPSV23 (Part A)
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=126 Participants
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in part A. In part B, a single IM dose of PCV15 will be given approximately between 10 to 18 months after V116.
|
|---|---|---|
|
Percentage of Participants With Vaccine-related SAEs From Day 1 of Part B Through the Duration of Participation in Part B
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 2.9
|
Adverse Events
V116 + Placebo (Part A)
Serious events: 4 serious events
Other events: 96 other events
Deaths: 1 deaths
PCV15 + PPSV23 (Part A)
Serious events: 6 serious events
Other events: 136 other events
Deaths: 0 deaths
V116 + Placebo (Part A), PCV15 (Part B)
Serious events: 1 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V116 + Placebo (Part A)
n=155 participants at risk
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A.
|
PCV15 + PPSV23 (Part A)
n=155 participants at risk
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=126 participants at risk
In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116 in participant who received V116 in Part A.
|
|---|---|---|---|
|
General disorders
Chest discomfort
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
General disorders
Death
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Nervous system disorders
Aphasia
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.65%
1/155 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/155 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.79%
1/126 • Number of events 1 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
Other adverse events
| Measure |
V116 + Placebo (Part A)
n=155 participants at risk
Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A.
|
PCV15 + PPSV23 (Part A)
n=155 participants at risk
Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
|
V116 + Placebo (Part A), PCV15 (Part B)
n=126 participants at risk
In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116 in participant who received V116 in Part A.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/155 • Number of events 2 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
5.8%
9/155 • Number of events 9 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
General disorders
Fatigue
|
30.3%
47/155 • Number of events 56 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
34.2%
53/155 • Number of events 68 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
22.2%
28/126 • Number of events 28 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
General disorders
Injection site erythema
|
3.9%
6/155 • Number of events 8 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
11.0%
17/155 • Number of events 19 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
0.00%
0/126 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
General disorders
Injection site pain
|
50.3%
78/155 • Number of events 93 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
82.6%
128/155 • Number of events 199 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
61.9%
78/126 • Number of events 78 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
General disorders
Injection site swelling
|
7.1%
11/155 • Number of events 13 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
20.6%
32/155 • Number of events 36 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
6.3%
8/126 • Number of events 8 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
20/155 • Number of events 22 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
15.5%
24/155 • Number of events 29 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
11.1%
14/126 • Number of events 14 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
|
Nervous system disorders
Headache
|
24.5%
38/155 • Number of events 48 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
20.0%
31/155 • Number of events 35 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
15.1%
19/126 • Number of events 20 • Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and all-cause mortality (ACM): Up to 194 days after the first vaccination Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
|
Additional Information
Senior Vice President, Global Clinical Development
MSD
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER