Trial Outcomes & Findings for Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (NCT NCT05696080)
NCT ID: NCT05696080
Last Updated: 2025-02-26
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
518 participants
Primary outcome timeframe
Up to 5 days following each vaccination
Results posted on
2025-02-26
Participant Flow
Pneumococcal vaccine-naïve adults 18 to 64 years of age (inclusive) with increased risk of pneumococcal disease were enrolled in this study. Participants must have had documented results of ≥ 1 of the following risk conditions: diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, and/or chronic lung disease. Participants with comorbidities were eligible if the conditions were assessed to be stable as per the investigator's judgment.
Participant milestones
| Measure |
V116 + Placebo
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Overall Study
STARTED
|
387
|
131
|
|
Overall Study
Vaccinated With V116 at Visit 2
|
386
|
0
|
|
Overall Study
Vaccinated With PCV15 at Visit 2
|
0
|
130
|
|
Overall Study
Vaccinated With Placebo at Visit 5
|
374
|
0
|
|
Overall Study
Vaccinated With PPSV23 at Visit 5
|
0
|
128
|
|
Overall Study
COMPLETED
|
372
|
129
|
|
Overall Study
NOT COMPLETED
|
15
|
2
|
Reasons for withdrawal
| Measure |
V116 + Placebo
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
0
|
Baseline Characteristics
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
Baseline characteristics by cohort
| Measure |
V116 + Placebo
n=387 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=131 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
Total
n=518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
52.6 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
101 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
281 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
294 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days following each vaccinationPopulation: 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.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination
Injection site erythema
|
9.1 Percentage of participants
Interval 6.4 to 12.4
|
25.4 Percentage of participants
Interval 18.2 to 33.8
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination
Injection site pain
|
51.8 Percentage of participants
Interval 46.7 to 56.9
|
78.5 Percentage of participants
Interval 70.4 to 85.2
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination
Injection site swelling
|
8.0 Percentage of participants
Interval 5.5 to 11.2
|
35.4 Percentage of participants
Interval 27.2 to 44.2
|
PRIMARY outcome
Timeframe: Up to 5 days following each vaccinationPopulation: 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.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs was assessed following any vaccination. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature \>= 100.4 °F/38.0 °C).
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination
Fatigue
|
30.3 Percentage of participants
Interval 25.8 to 35.2
|
45.4 Percentage of participants
Interval 36.6 to 54.3
|
|
Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination
Headache
|
22.3 Percentage of participants
Interval 18.2 to 26.8
|
26.2 Percentage of participants
Interval 18.8 to 34.6
|
|
Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination
Myalgia
|
10.9 Percentage of participants
Interval 8.0 to 14.4
|
15.4 Percentage of participants
Interval 9.7 to 22.8
|
|
Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination
Pyrexia
|
3.1 Percentage of participants
Interval 1.6 to 5.4
|
4.6 Percentage of participants
Interval 1.7 to 9.8
|
PRIMARY outcome
Timeframe: Up to 194 days following Visit 2 (Day 1)Population: 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.
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study
|
0.0 Percentage of participants
Interval 0.0 to 1.0
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
PRIMARY outcome
Timeframe: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 3
|
216.2 Titers
Interval 188.6 to 247.8
|
192.9 Titers
Interval 156.7 to 237.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 6A
|
3734.9 Titers
Interval 3204.3 to 4353.4
|
2443.8 Titers
Interval 1779.0 to 3357.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 7F
|
4261.2 Titers
Interval 3781.6 to 4801.6
|
3218.5 Titers
Interval 2627.3 to 3942.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 8
|
3460.8 Titers
Interval 3083.1 to 3884.7
|
3406.4 Titers
Interval 2635.8 to 4402.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 9N
|
7553.9 Titers
Interval 6664.1 to 8562.5
|
4548.4 Titers
Interval 3696.8 to 5596.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 10A
|
4502.0 Titers
Interval 3933.7 to 5152.4
|
2542.0 Titers
Interval 1897.0 to 3406.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 11A
|
3761.7 Titers
Interval 3375.8 to 4191.7
|
1697.2 Titers
Interval 1338.4 to 2152.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 12F
|
2432.3 Titers
Interval 2082.7 to 2840.6
|
1364.5 Titers
Interval 956.1 to 1947.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 17F
|
10425.3 Titers
Interval 9099.2 to 11944.7
|
4331.7 Titers
Interval 3248.3 to 5776.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 19A
|
2837.2 Titers
Interval 2535.2 to 3175.2
|
2437.2 Titers
Interval 2008.5 to 2957.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 20A
|
8091.5 Titers
Interval 7169.4 to 9132.3
|
3749.8 Titers
Interval 2932.4 to 4795.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 22F
|
4432.7 Titers
Interval 3914.2 to 5020.0
|
2717.4 Titers
Interval 2201.7 to 3353.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 33F
|
24512.8 Titers
Interval 21149.8 to 28410.7
|
11395.1 Titers
Interval 8884.5 to 14615.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 15A
|
7274.6 Titers
Interval 6398.7 to 8270.4
|
1791.8 Titers
Interval 1361.7 to 2357.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 15C
|
7923.1 Titers
Interval 6726.7 to 9332.3
|
2269.8 Titers
Interval 1651.8 to 3118.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 16F
|
9546.6 Titers
Interval 8396.2 to 10854.6
|
1626.2 Titers
Interval 1224.4 to 2159.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 23A
|
5875.3 Titers
Interval 5005.5 to 6896.2
|
1493.9 Titers
Interval 1009.1 to 2211.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 23B
|
2316.9 Titers
Interval 1925.9 to 2787.3
|
117.0 Titers
Interval 73.4 to 186.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 24F
|
5677.1 Titers
Interval 5098.2 to 6321.8
|
1666.8 Titers
Interval 1257.6 to 2209.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 31
|
5803.9 Titers
Interval 4991.8 to 6748.1
|
360.7 Titers
Interval 233.0 to 558.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
Serotype 35B
|
13141.3 Titers
Interval 11584.8 to 14906.9
|
1812.1 Titers
Interval 1408.6 to 2331.2
|
SECONDARY outcome
Timeframe: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 3
|
0.77 μg/mL
Interval 0.69 to 0.87
|
0.79 μg/mL
Interval 0.68 to 0.92
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 6A
|
4.57 μg/mL
Interval 3.82 to 5.48
|
5.83 μg/mL
Interval 4.23 to 8.03
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 7F
|
8.77 μg/mL
Interval 7.65 to 10.06
|
6.95 μg/mL
Interval 5.39 to 8.96
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 8
|
10.20 μg/mL
Interval 8.89 to 11.71
|
12.50 μg/mL
Interval 9.68 to 16.14
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 9N
|
7.53 μg/mL
Interval 6.42 to 8.83
|
4.35 μg/mL
Interval 3.35 to 5.66
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 10A
|
12.18 μg/mL
Interval 10.36 to 14.32
|
6.88 μg/mL
Interval 5.07 to 9.34
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 11A
|
7.78 μg/mL
Interval 6.8 to 8.89
|
4.04 μg/mL
Interval 3.22 to 5.07
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 12F
|
1.90 μg/mL
Interval 1.58 to 2.28
|
0.84 μg/mL
Interval 0.6 to 1.18
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 17F
|
17.35 μg/mL
Interval 15.06 to 19.98
|
8.20 μg/mL
Interval 6.32 to 10.64
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 19A
|
9.11 μg/mL
Interval 7.98 to 10.41
|
10.88 μg/mL
Interval 8.7 to 13.6
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 20A
|
19.51 μg/mL
Interval 16.73 to 22.75
|
13.38 μg/mL
Interval 10.27 to 17.43
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 22F
|
5.17 μg/mL
Interval 4.44 to 6.02
|
3.98 μg/mL
Interval 3.08 to 5.14
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 33F
|
15.38 μg/mL
Interval 13.23 to 17.88
|
11.40 μg/mL
Interval 8.99 to 14.46
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 15A
|
14.65 μg/mL
Interval 12.52 to 17.13
|
2.37 μg/mL
Interval 1.77 to 3.18
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 15C
|
14.48 μg/mL
Interval 12.07 to 17.38
|
5.42 μg/mL
Interval 3.98 to 7.37
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 16F
|
2.90 μg/mL
Interval 2.48 to 3.38
|
0.27 μg/mL
Interval 0.21 to 0.35
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 23A
|
3.85 μg/mL
Interval 3.18 to 4.66
|
0.79 μg/mL
Interval 0.56 to 1.11
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 23B
|
6.62 μg/mL
Interval 5.75 to 7.63
|
1.46 μg/mL
Interval 1.09 to 1.96
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 24F
|
5.18 μg/mL
Interval 4.17 to 6.43
|
0.34 μg/mL
Interval 0.26 to 0.43
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 31
|
3.27 μg/mL
Interval 2.83 to 3.79
|
0.38 μg/mL
Interval 0.29 to 0.49
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
Serotype 35B
|
19.78 μg/mL
Interval 17.38 to 22.5
|
1.55 μg/mL
Interval 1.27 to 1.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 3
|
8.3 Ratio
Interval 7.2 to 9.5
|
6.1 Ratio
Interval 4.8 to 7.7
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 6A
|
22.8 Ratio
Interval 18.6 to 28.0
|
17.1 Ratio
Interval 11.9 to 24.7
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 7F
|
20.4 Ratio
Interval 16.9 to 24.6
|
10.5 Ratio
Interval 7.5 to 14.7
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 8
|
25.7 Ratio
Interval 21.1 to 31.2
|
25.2 Ratio
Interval 17.0 to 37.1
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 9N
|
12.6 Ratio
Interval 10.6 to 15.0
|
7.2 Ratio
Interval 5.5 to 9.5
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 10A
|
19.9 Ratio
Interval 16.1 to 24.5
|
10.7 Ratio
Interval 7.2 to 15.8
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 11A
|
20.7 Ratio
Interval 16.6 to 25.8
|
6.8 Ratio
Interval 4.6 to 10.1
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 12F
|
95.0 Ratio
Interval 79.9 to 113.0
|
48.6 Ratio
Interval 32.5 to 72.6
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 17F
|
28.4 Ratio
Interval 23.6 to 34.2
|
13.1 Ratio
Interval 9.5 to 18.1
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 19A
|
9.7 Ratio
Interval 8.2 to 11.5
|
9.9 Ratio
Interval 7.2 to 13.6
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 20A
|
8.5 Ratio
Interval 7.2 to 10.0
|
3.8 Ratio
Interval 3.0 to 5.0
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 22F
|
15.1 Ratio
Interval 12.2 to 18.7
|
9.1 Ratio
Interval 6.0 to 13.7
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 33F
|
12.3 Ratio
Interval 10.4 to 14.5
|
5.5 Ratio
Interval 4.1 to 7.2
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 15A
|
10.4 Ratio
Interval 8.6 to 12.5
|
2.4 Ratio
Interval 1.8 to 3.2
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 15C
|
52.8 Ratio
Interval 42.1 to 66.2
|
18.3 Ratio
Interval 12.2 to 27.4
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 16F
|
8.6 Ratio
Interval 7.3 to 10.1
|
1.6 Ratio
Interval 1.2 to 2.0
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 23A
|
14.5 Ratio
Interval 11.4 to 18.6
|
4.3 Ratio
Interval 2.7 to 6.8
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 23B
|
83.6 Ratio
Interval 66.4 to 105.3
|
6.2 Ratio
Interval 4.3 to 9.0
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 24F
|
4.0 Ratio
Interval 3.4 to 4.7
|
0.9 Ratio
Interval 0.7 to 1.2
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 31
|
23.2 Ratio
Interval 18.4 to 29.1
|
1.5 Ratio
Interval 1.2 to 2.0
|
|
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 35B
|
7.2 Ratio
Interval 6.3 to 8.3
|
1.2 Ratio
Interval 1.0 to 1.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 3
|
5.2 Ratio
Interval 4.7 to 5.8
|
4.5 Ratio
Interval 3.8 to 5.4
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 6A
|
16.2 Ratio
Interval 13.9 to 18.9
|
20.1 Ratio
Interval 15.5 to 26.0
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 7F
|
19.0 Ratio
Interval 16.8 to 21.5
|
12.8 Ratio
Interval 10.2 to 16.2
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 8
|
14.8 Ratio
Interval 12.9 to 17.0
|
15.5 Ratio
Interval 11.5 to 21.0
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 9N
|
19.2 Ratio
Interval 16.8 to 22.0
|
9.9 Ratio
Interval 7.9 to 12.5
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 10A
|
20.1 Ratio
Interval 17.6 to 23.0
|
11.0 Ratio
Interval 8.6 to 13.9
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 11A
|
11.7 Ratio
Interval 10.3 to 13.3
|
5.6 Ratio
Interval 4.5 to 7.0
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 12F
|
17.7 Ratio
Interval 15.3 to 20.5
|
8.1 Ratio
Interval 6.2 to 10.6
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 17F
|
29.6 Ratio
Interval 25.9 to 33.8
|
13.9 Ratio
Interval 10.9 to 17.6
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 19A
|
7.1 Ratio
Interval 6.3 to 8.0
|
8.1 Ratio
Interval 6.5 to 10.0
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 20A
|
15.1 Ratio
Interval 13.2 to 17.2
|
8.7 Ratio
Interval 7.0 to 10.8
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 22F
|
19.7 Ratio
Interval 17.0 to 22.8
|
13.2 Ratio
Interval 10.2 to 17.3
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 33F
|
14.7 Ratio
Interval 13.0 to 16.6
|
11.0 Ratio
Interval 8.8 to 13.8
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 15A
|
23.6 Ratio
Interval 20.6 to 27.1
|
3.7 Ratio
Interval 3.0 to 4.6
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 15C
|
24.2 Ratio
Interval 20.8 to 28.2
|
9.2 Ratio
Interval 7.3 to 11.7
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 16F
|
16.0 Ratio
Interval 14.1 to 18.1
|
1.6 Ratio
Interval 1.4 to 1.9
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 23A
|
20.9 Ratio
Interval 18.2 to 24.0
|
3.8 Ratio
Interval 2.9 to 4.9
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 23B
|
16.6 Ratio
Interval 14.3 to 19.2
|
3.7 Ratio
Interval 3.0 to 4.6
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 24F
|
18.0 Ratio
Interval 15.5 to 20.9
|
1.1 Ratio
Interval 1.1 to 1.2
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 31
|
14.4 Ratio
Interval 12.7 to 16.4
|
1.5 Ratio
Interval 1.4 to 1.7
|
|
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
Serotype 35B
|
12.8 Ratio
Interval 11.3 to 14.5
|
1.0 Ratio
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 3
|
70.1 Percentage of Participants
Interval 64.8 to 74.9
|
63.7 Percentage of Participants
Interval 53.6 to 73.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 6A
|
79.1 Percentage of Participants
Interval 74.1 to 83.6
|
79.3 Percentage of Participants
Interval 68.9 to 87.4
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 7F
|
78.3 Percentage of Participants
Interval 73.5 to 82.6
|
63.6 Percentage of Participants
Interval 53.7 to 72.6
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 8
|
84.6 Percentage of Participants
Interval 80.3 to 88.2
|
82.5 Percentage of Participants
Interval 73.8 to 89.3
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 9N
|
74.7 Percentage of Participants
Interval 69.7 to 79.3
|
58.9 Percentage of Participants
Interval 49.0 to 68.3
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 10A
|
74.9 Percentage of Participants
Interval 69.9 to 79.5
|
70.4 Percentage of Participants
Interval 60.3 to 79.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 11A
|
76.7 Percentage of Participants
Interval 71.7 to 81.2
|
49.0 Percentage of Participants
Interval 38.9 to 59.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 12F
|
94.2 Percentage of Participants
Interval 91.1 to 96.4
|
85.0 Percentage of Participants
Interval 76.9 to 91.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 17F
|
89.6 Percentage of Participants
Interval 85.8 to 92.7
|
76.2 Percentage of Participants
Interval 66.7 to 84.1
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 19A
|
68.0 Percentage of Participants
Interval 62.7 to 72.9
|
68.6 Percentage of Participants
Interval 58.7 to 77.5
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 20A
|
66.9 Percentage of Participants
Interval 61.5 to 71.9
|
42.3 Percentage of Participants
Interval 32.3 to 52.7
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 22F
|
74.8 Percentage of Participants
Interval 69.7 to 79.5
|
57.8 Percentage of Participants
Interval 47.7 to 67.6
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 33F
|
78.5 Percentage of Participants
Interval 73.7 to 82.8
|
58.0 Percentage of Participants
Interval 47.7 to 67.8
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 15A
|
67.6 Percentage of Participants
Interval 62.1 to 72.8
|
29.5 Percentage of Participants
Interval 20.6 to 39.7
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 15C
|
86.0 Percentage of Participants
Interval 81.8 to 89.5
|
72.4 Percentage of Participants
Interval 62.8 to 80.7
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 16F
|
65.6 Percentage of Participants
Interval 60.2 to 70.7
|
16.7 Percentage of Participants
Interval 9.8 to 25.6
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 23A
|
71.3 Percentage of Participants
Interval 65.4 to 76.7
|
52.6 Percentage of Participants
Interval 40.8 to 64.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 23B
|
87.7 Percentage of Participants
Interval 83.7 to 91.0
|
49.1 Percentage of Participants
Interval 39.2 to 59.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 24F
|
41.6 Percentage of Participants
Interval 35.9 to 47.5
|
6.2 Percentage of Participants
Interval 2.0 to 13.8
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 31
|
77.0 Percentage of Participants
Interval 72.2 to 81.4
|
16.2 Percentage of Participants
Interval 9.5 to 24.9
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
Serotype 35B
|
64.4 Percentage of Participants
Interval 59.0 to 69.5
|
5.9 Percentage of Participants
Interval 2.2 to 12.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)Population: The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include, but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window.
The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.
Outcome measures
| Measure |
V116 + Placebo
n=386 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 Participants
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 3
|
57.8 Percentage of Participants
Interval 52.6 to 62.9
|
54.1 Percentage of Participants
Interval 44.3 to 63.6
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 6A
|
81.1 Percentage of Participants
Interval 76.8 to 85.0
|
86.5 Percentage of Participants
Interval 78.7 to 92.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 7F
|
88.8 Percentage of Participants
Interval 85.1 to 91.8
|
83.8 Percentage of Participants
Interval 75.6 to 90.1
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 8
|
82.2 Percentage of Participants
Interval 77.9 to 86.0
|
83.8 Percentage of Participants
Interval 75.6 to 90.1
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 9N
|
86.9 Percentage of Participants
Interval 83.0 to 90.2
|
78.4 Percentage of Participants
Interval 69.6 to 85.6
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 10A
|
86.3 Percentage of Participants
Interval 82.4 to 89.7
|
79.3 Percentage of Participants
Interval 70.5 to 86.4
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 11A
|
79.8 Percentage of Participants
Interval 75.3 to 83.8
|
63.1 Percentage of Participants
Interval 53.4 to 72.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 12F
|
82.8 Percentage of Participants
Interval 78.5 to 86.5
|
69.4 Percentage of Participants
Interval 59.9 to 77.8
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 17F
|
93.2 Percentage of Participants
Interval 90.1 to 95.5
|
82.9 Percentage of Participants
Interval 74.6 to 89.4
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 19A
|
64.2 Percentage of Participants
Interval 59.1 to 69.1
|
73.0 Percentage of Participants
Interval 63.7 to 81.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 20A
|
83.1 Percentage of Participants
Interval 78.8 to 86.8
|
75.7 Percentage of Participants
Interval 66.6 to 83.3
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 22F
|
85.0 Percentage of Participants
Interval 80.9 to 88.5
|
83.8 Percentage of Participants
Interval 75.6 to 90.1
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 33F
|
87.2 Percentage of Participants
Interval 83.3 to 90.4
|
79.3 Percentage of Participants
Interval 70.5 to 86.4
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 15A
|
88.3 Percentage of Participants
Interval 84.5 to 91.4
|
44.1 Percentage of Participants
Interval 34.7 to 53.9
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 15C
|
88.5 Percentage of Participants
Interval 84.8 to 91.6
|
75.5 Percentage of Participants
Interval 66.3 to 83.2
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 16F
|
85.8 Percentage of Participants
Interval 81.8 to 89.2
|
7.3 Percentage of Participants
Interval 3.2 to 13.8
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 23A
|
88.3 Percentage of Participants
Interval 84.5 to 91.4
|
37.8 Percentage of Participants
Interval 28.8 to 47.5
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 23B
|
81.7 Percentage of Participants
Interval 77.3 to 85.5
|
43.2 Percentage of Participants
Interval 33.9 to 53.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 24F
|
82.0 Percentage of Participants
Interval 77.6 to 85.8
|
2.7 Percentage of Participants
Interval 0.6 to 7.7
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 31
|
83.1 Percentage of Participants
Interval 78.8 to 86.8
|
9.9 Percentage of Participants
Interval 5.1 to 17.0
|
|
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
Serotype 35B
|
79.5 Percentage of Participants
Interval 75.0 to 83.5
|
0.9 Percentage of Participants
Interval 0.0 to 4.9
|
Adverse Events
V116 + Placebo
Serious events: 10 serious events
Other events: 240 other events
Deaths: 0 deaths
PCV15 + PPSV23
Serious events: 7 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V116 + Placebo
n=386 participants at risk
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 participants at risk
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Infections and infestations
Urosepsis
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Nervous system disorders
Seizure
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Vascular disorders
Aortic stenosis
|
0.26%
1/386 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.00%
0/130 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/386 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
0.77%
1/130 • Number of events 1 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
Other adverse events
| Measure |
V116 + Placebo
n=386 participants at risk
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8).
|
PCV15 + PPSV23
n=130 participants at risk
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8).
|
|---|---|---|
|
General disorders
Fatigue
|
30.6%
118/386 • Number of events 152 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
45.4%
59/130 • Number of events 75 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
General disorders
Injection site erythema
|
10.1%
39/386 • Number of events 41 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
25.4%
33/130 • Number of events 36 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
General disorders
Injection site pain
|
51.8%
200/386 • Number of events 223 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
78.5%
102/130 • Number of events 176 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
General disorders
Injection site swelling
|
8.5%
33/386 • Number of events 37 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
35.4%
46/130 • Number of events 55 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
42/386 • Number of events 50 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
15.4%
20/130 • Number of events 22 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
|
Nervous system disorders
Headache
|
24.4%
94/386 • Number of events 116 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
27.7%
36/130 • Number of events 46 • Up to ~ 194 Days following Visit 2 (Day 1)
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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER