Trial Outcomes & Findings for Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9) (NCT NCT05633992)
NCT ID: NCT05633992
Last Updated: 2024-10-02
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
450 participants
Primary outcome timeframe
Up to 5 days postvaccination
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
V116
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
225
|
|
Overall Study
COMPLETED
|
225
|
225
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis population consists of all randomized participants who had available baseline data.
Baseline characteristics by cohort
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 Years
STANDARD_DEVIATION 5.7 • n=225 Participants
|
70.9 Years
STANDARD_DEVIATION 5.6 • n=225 Participants
|
70.9 Years
STANDARD_DEVIATION 5.7 • n=450 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=225 Participants
|
96 Participants
n=225 Participants
|
195 Participants
n=450 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=225 Participants
|
129 Participants
n=225 Participants
|
255 Participants
n=450 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
225 Participants
n=225 Participants
|
225 Participants
n=225 Participants
|
450 Participants
n=450 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
Asian
|
225 Participants
n=225 Participants
|
225 Participants
n=225 Participants
|
450 Participants
n=450 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=225 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=450 Participants
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 6A
|
108.5 Titers
n=192 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
149.1 Titers
n=205 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
127.9 Titers
n=397 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 15A
|
387.0 Titers
n=194 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
416.4 Titers
n=191 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
401.3 Titers
n=385 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 16F
|
820.5 Titers
n=205 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
757.9 Titers
n=215 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
787.8 Titers
n=420 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 23A
|
324.0 Titers
n=162 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
344.8 Titers
n=152 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
333.9 Titers
n=314 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 23B
|
36.6 Titers
n=207 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
41.2 Titers
n=216 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
38.9 Titers
n=423 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 24F
|
627.6 Titers
n=202 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
641.9 Titers
n=199 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
634.6 Titers
n=401 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 31
|
129.0 Titers
n=219 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
176.5 Titers
n=221 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
151.0 Titers
n=440 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
|
Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT)
Serotype 35B
|
852.6 Titers
n=222 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
937.0 Titers
n=221 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
893.7 Titers
n=443 Participants • The analysis population consists of all randomized participants who had available baseline data.
|
PRIMARY outcome
Timeframe: Up to 5 days postvaccinationPopulation: The analysis population includes all participants who received ≥1 dose of study treatment.
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 solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
|
32.9 Percentage of participants
|
39.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 5 days postvaccinationPopulation: The analysis population includes all participants who received ≥1 dose of study treatment.
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 solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs
|
17.3 Percentage of participants
|
16.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 30 days postvaccinationPopulation: The analysis population includes all participants who received ≥1 dose of study treatment.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Vaccine-related Serious AEs (SAEs)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results.
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 3
|
155.1 Titers
Interval 133.6 to 180.1
|
170.8 Titers
Interval 143.9 to 202.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 7F
|
2675.1 Titers
Interval 2312.9 to 3094.0
|
2411.4 Titers
Interval 2054.5 to 2830.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 8
|
1293.3 Titers
Interval 1133.8 to 1475.2
|
1142.4 Titers
Interval 988.3 to 1320.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 9N
|
2844.8 Titers
Interval 2492.7 to 3246.6
|
2710.5 Titers
Interval 2297.6 to 3197.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 10A
|
1591.2 Titers
Interval 1367.4 to 1851.7
|
880.2 Titers
Interval 690.1 to 1122.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 11A
|
1269.6 Titers
Interval 1057.6 to 1524.1
|
887.9 Titers
Interval 748.3 to 1053.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 12F
|
968.5 Titers
Interval 792.5 to 1183.6
|
503.7 Titers
Interval 383.8 to 661.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 17F
|
3138.1 Titers
Interval 2673.0 to 3684.2
|
1860.3 Titers
Interval 1551.8 to 2230.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 19A
|
1338.4 Titers
Interval 1144.3 to 1565.4
|
1140.7 Titers
Interval 925.1 to 1406.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 20A
|
2617.2 Titers
Interval 2212.9 to 3095.5
|
1731.5 Titers
Interval 1474.1 to 2033.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 22F
|
1830.9 Titers
Interval 1562.4 to 2145.6
|
1295.5 Titers
Interval 1072.6 to 1564.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 33F
|
7692.4 Titers
Interval 6349.4 to 9319.4
|
8610.8 Titers
Interval 7029.9 to 10547.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 15C
|
2488.5 Titers
Interval 1993.5 to 3106.6
|
1185.0 Titers
Interval 954.1 to 1471.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Day 30, Serotype 15B
|
2081.1 Titers
Interval 1675.0 to 2585.7
|
1479.7 Titers
Interval 1218.0 to 1797.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 3
|
14.2 Titers
Interval 12.5 to 16.1
|
14.9 Titers
Interval 13.1 to 17.0
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 7F
|
243.9 Titers
Interval 190.8 to 311.7
|
217.6 Titers
Interval 168.8 to 280.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 8
|
48.8 Titers
Interval 38.3 to 62.3
|
46.3 Titers
Interval 36.7 to 58.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 9N
|
383.1 Titers
Interval 313.3 to 468.4
|
383.2 Titers
Interval 314.6 to 466.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 10A
|
131.5 Titers
Interval 101.3 to 170.6
|
103.5 Titers
Interval 77.4 to 138.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 11A
|
75.2 Titers
Interval 55.9 to 101.3
|
91.2 Titers
Interval 68.3 to 121.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 12F
|
18.1 Titers
Interval 14.7 to 22.3
|
19.2 Titers
Interval 15.6 to 23.7
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 17F
|
285.8 Titers
Interval 225.7 to 361.8
|
226.8 Titers
Interval 181.0 to 284.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 19A
|
188.1 Titers
Interval 151.9 to 232.8
|
179.7 Titers
Interval 143.4 to 225.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 20A
|
460.0 Titers
Interval 384.4 to 550.6
|
421.1 Titers
Interval 348.9 to 508.1
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 22F
|
179.9 Titers
Interval 138.0 to 234.7
|
167.9 Titers
Interval 128.0 to 220.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 33F
|
1236.7 Titers
Interval 1048.1 to 1459.3
|
1198.9 Titers
Interval 1004.3 to 1431.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 15C
|
110.0 Titers
Interval 85.2 to 142.1
|
102.6 Titers
Interval 79.4 to 132.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
Baseline, Serotype 15B
|
243.3 Titers
Interval 194.6 to 304.1
|
251.7 Titers
Interval 199.7 to 317.2
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=224 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 6A
|
72.8 Percentage of Participants
|
45.3 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 15A
|
59.7 Percentage of Participants
|
26.0 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 16F
|
50.3 Percentage of Participants
|
11.9 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 23A
|
57.6 Percentage of Participants
|
27.9 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 23B
|
82.1 Percentage of Participants
|
43.7 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 24F
|
42.9 Percentage of Participants
|
16.0 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 31
|
70.3 Percentage of Participants
|
13.1 Percentage of Participants
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
Serotype 35B
|
52.9 Percentage of Participants
|
6.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available.
The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=224 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 6A
|
1263.8 Titers
Interval 1036.6 to 1540.7
|
641.8 Titers
Interval 507.0 to 812.4
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 15A
|
2752.3 Titers
Interval 2319.8 to 3265.5
|
832.2 Titers
Interval 687.4 to 1007.6
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 16F
|
4094.8 Titers
Interval 3574.8 to 4690.4
|
1183.9 Titers
Interval 987.2 to 1419.7
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 23A
|
2107.5 Titers
Interval 1702.3 to 2609.1
|
729.2 Titers
Interval 556.8 to 955.0
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 23B
|
1359.0 Titers
Interval 1086.7 to 1699.5
|
202.2 Titers
Interval 146.5 to 279.2
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 24F
|
2521.9 Titers
Interval 2246.2 to 2831.4
|
1043.8 Titers
Interval 878.1 to 1240.7
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 31
|
2095.4 Titers
Interval 1746.3 to 2514.2
|
260.7 Titers
Interval 200.9 to 338.2
|
|
Serotype-specific OPA GMTs (Unique Serotypes)
Serotype 35B
|
4758.1 Titers
Interval 4146.5 to 5459.9
|
1051.4 Titers
Interval 886.6 to 1246.9
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data available.
The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 3
|
0.54 µg/mL
Interval 0.47 to 0.61
|
0.58 µg/mL
Interval 0.51 to 0.67
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 7F
|
6.12 µg/mL
Interval 5.13 to 7.31
|
4.25 µg/mL
Interval 3.5 to 5.14
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 8
|
8.13 µg/mL
Interval 7.01 to 9.42
|
6.72 µg/mL
Interval 5.87 to 7.71
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 9N
|
7.49 µg/mL
Interval 6.23 to 9.01
|
5.44 µg/mL
Interval 4.55 to 6.5
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 10A
|
8.21 µg/mL
Interval 6.64 to 10.15
|
3.84 µg/mL
Interval 3.09 to 4.79
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 11A
|
6.00 µg/mL
Interval 5.09 to 7.08
|
3.02 µg/mL
Interval 2.59 to 3.52
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 12F
|
1.55 µg/mL
Interval 1.23 to 1.95
|
0.66 µg/mL
Interval 0.52 to 0.84
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 17F
|
10.48 µg/mL
Interval 8.77 to 12.52
|
5.08 µg/mL
Interval 4.32 to 5.98
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 19A
|
5.70 µg/mL
Interval 4.8 to 6.76
|
4.87 µg/mL
Interval 4.07 to 5.83
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 20A
|
15.61 µg/mL
Interval 13.2 to 18.47
|
9.78 µg/mL
Interval 8.09 to 11.83
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 22F
|
2.84 µg/mL
Interval 2.28 to 3.52
|
1.39 µg/mL
Interval 1.14 to 1.69
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 33F
|
13.93 µg/mL
Interval 11.92 to 16.27
|
12.67 µg/mL
Interval 10.9 to 14.74
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 6A
|
3.42 µg/mL
Interval 2.74 to 4.26
|
1.64 µg/mL
Interval 1.33 to 2.02
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 15A
|
9.98 µg/mL
Interval 8.14 to 12.25
|
1.64 µg/mL
Interval 1.35 to 1.98
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 15C
|
9.87 µg/mL
Interval 7.95 to 12.26
|
4.55 µg/mL
Interval 3.69 to 5.6
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 16F
|
3.07 µg/mL
Interval 2.56 to 3.68
|
0.37 µg/mL
Interval 0.31 to 0.43
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 23A
|
2.00 µg/mL
Interval 1.6 to 2.51
|
0.32 µg/mL
Interval 0.27 to 0.39
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 23B
|
4.22 µg/mL
Interval 3.58 to 4.99
|
1.65 µg/mL
Interval 1.37 to 1.98
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 24F
|
7.79 µg/mL
Interval 6.26 to 9.71
|
0.41 µg/mL
Interval 0.35 to 0.47
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 31
|
2.57 µg/mL
Interval 2.16 to 3.07
|
0.40 µg/mL
Interval 0.34 to 0.46
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 35B
|
14.19 µg/mL
Interval 12.01 to 16.76
|
1.38 µg/mL
Interval 1.19 to 1.6
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 6C
|
1.19 µg/mL
Interval 0.97 to 1.46
|
0.50 µg/mL
Interval 0.42 to 0.59
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
Serotype 15B
|
10.15 µg/mL
Interval 8.35 to 12.35
|
9.86 µg/mL
Interval 8.4 to 11.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=224 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 3
|
7.2 Ratio
Interval 6.1 to 8.5
|
7.2 Ratio
Interval 6.1 to 8.5
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 7F
|
10.0 Ratio
Interval 8.0 to 12.6
|
9.8 Ratio
Interval 8.0 to 12.1
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 8
|
20.6 Ratio
Interval 16.4 to 25.8
|
19.1 Ratio
Interval 15.5 to 23.7
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 9N
|
6.9 Ratio
Interval 5.6 to 8.5
|
6.6 Ratio
Interval 5.3 to 8.1
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 10A
|
10.1 Ratio
Interval 8.2 to 12.4
|
7.6 Ratio
Interval 5.9 to 9.9
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 11A
|
13.6 Ratio
Interval 10.5 to 17.7
|
7.3 Ratio
Interval 5.7 to 9.4
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 12F
|
32.2 Ratio
Interval 25.7 to 40.3
|
17.1 Ratio
Interval 13.2 to 22.1
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 17F
|
9.8 Ratio
Interval 7.8 to 12.4
|
7.1 Ratio
Interval 5.9 to 8.6
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 19A
|
6.7 Ratio
Interval 5.5 to 8.1
|
5.8 Ratio
Interval 4.8 to 6.9
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 20A
|
5.6 Ratio
Interval 4.7 to 6.6
|
4.1 Ratio
Interval 3.4 to 4.8
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 22F
|
8.9 Ratio
Interval 6.9 to 11.5
|
6.9 Ratio
Interval 5.4 to 8.8
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 33F
|
6.4 Ratio
Interval 5.2 to 7.8
|
7.3 Ratio
Interval 6.0 to 8.8
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 6A
|
9.4 Ratio
Interval 7.5 to 11.6
|
3.7 Ratio
Interval 3.0 to 4.5
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 15A
|
6.7 Ratio
Interval 5.3 to 8.5
|
2.0 Ratio
Interval 1.6 to 2.4
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 15C
|
19.1 Ratio
Interval 15.2 to 24.1
|
9.3 Ratio
Interval 7.4 to 11.7
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 16F
|
4.7 Ratio
Interval 4.0 to 5.6
|
1.5 Ratio
Interval 1.4 to 1.7
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 23A
|
5.9 Ratio
Interval 4.2 to 8.2
|
1.8 Ratio
Interval 1.4 to 2.4
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 23B
|
26.2 Ratio
Interval 20.5 to 33.6
|
4.2 Ratio
Interval 3.3 to 5.4
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 24F
|
3.8 Ratio
Interval 3.1 to 4.6
|
1.5 Ratio
Interval 1.2 to 1.8
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 31
|
13.6 Ratio
Interval 10.6 to 17.3
|
1.4 Ratio
Interval 1.2 to 1.6
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 35B
|
5.5 Ratio
Interval 4.6 to 6.5
|
1.2 Ratio
Interval 1.0 to 1.3
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 6C
|
2.9 Ratio
Interval 2.4 to 3.7
|
2.0 Ratio
Interval 1.7 to 2.3
|
|
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
Serotype 15B
|
7.4 Ratio
Interval 5.7 to 9.5
|
4.8 Ratio
Interval 3.7 to 6.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Serotype-specific GMFR in IgG GMCs
Serotype 6C
|
2.7 Ratio
Interval 2.3 to 3.2
|
1.3 Ratio
Interval 1.2 to 1.4
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 15B
|
6.8 Ratio
Interval 5.7 to 8.2
|
7.3 Ratio
Interval 6.3 to 8.6
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 3
|
5.0 Ratio
Interval 4.5 to 5.7
|
5.1 Ratio
Interval 4.5 to 5.8
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 7F
|
12.1 Ratio
Interval 10.2 to 14.3
|
8.3 Ratio
Interval 7.1 to 9.7
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 8
|
11.6 Ratio
Interval 9.8 to 13.7
|
9.8 Ratio
Interval 8.4 to 11.3
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 9N
|
11.8 Ratio
Interval 9.8 to 14.3
|
9.8 Ratio
Interval 8.4 to 11.5
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 10A
|
11.4 Ratio
Interval 9.7 to 13.4
|
6.4 Ratio
Interval 5.5 to 7.4
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 11A
|
8.0 Ratio
Interval 6.8 to 9.4
|
3.9 Ratio
Interval 3.5 to 4.4
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 12F
|
11.9 Ratio
Interval 9.8 to 14.6
|
6.3 Ratio
Interval 5.2 to 7.5
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 17F
|
12.9 Ratio
Interval 10.9 to 15.2
|
7.0 Ratio
Interval 6.1 to 8.1
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 19A
|
5.1 Ratio
Interval 4.3 to 5.9
|
4.2 Ratio
Interval 3.7 to 4.9
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 20A
|
9.5 Ratio
Interval 8.1 to 11.2
|
6.2 Ratio
Interval 5.4 to 7.2
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 22F
|
10.7 Ratio
Interval 8.9 to 12.9
|
5.7 Ratio
Interval 4.8 to 6.6
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 33F
|
8.7 Ratio
Interval 7.4 to 10.2
|
7.7 Ratio
Interval 6.6 to 8.9
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 6A
|
10.4 Ratio
Interval 8.7 to 12.5
|
4.1 Ratio
Interval 3.6 to 4.7
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 15A
|
14.0 Ratio
Interval 11.8 to 16.5
|
2.7 Ratio
Interval 2.4 to 3.1
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 15C
|
14.3 Ratio
Interval 11.8 to 17.3
|
6.9 Ratio
Interval 5.9 to 8.1
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 16F
|
12.8 Ratio
Interval 11.0 to 14.9
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 23A
|
12.0 Ratio
Interval 10.1 to 14.4
|
2.0 Ratio
Interval 1.8 to 2.2
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 23B
|
8.6 Ratio
Interval 7.5 to 10.0
|
3.1 Ratio
Interval 2.8 to 3.5
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 24F
|
18.0 Ratio
Interval 15.2 to 21.2
|
1.1 Ratio
Interval 1.0 to 1.1
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 31
|
9.1 Ratio
Interval 8.0 to 10.5
|
1.5 Ratio
Interval 1.3 to 1.6
|
|
Serotype-specific GMFR in IgG GMCs
Serotype 35B
|
12.7 Ratio
Interval 10.8 to 14.8
|
1.1 Ratio
Interval 1.0 to 1.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=224 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 3
|
73.8 Percentage of Participants
Interval 66.9 to 79.9
|
71.3 Percentage of Participants
Interval 64.4 to 77.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 7F
|
68.5 Percentage of Participants
Interval 61.9 to 74.7
|
69.6 Percentage of Participants
Interval 63.0 to 75.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 8
|
79.8 Percentage of Participants
Interval 73.8 to 85.0
|
81.0 Percentage of Participants
Interval 75.1 to 86.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 9N
|
57.6 Percentage of Participants
Interval 50.0 to 65.0
|
58.8 Percentage of Participants
Interval 51.1 to 66.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 10A
|
69.3 Percentage of Participants
Interval 62.4 to 75.6
|
59.7 Percentage of Participants
Interval 52.4 to 66.7
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 11A
|
69.3 Percentage of Participants
Interval 62.4 to 75.6
|
55.8 Percentage of Participants
Interval 48.6 to 62.9
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 12F
|
84.3 Percentage of Participants
Interval 78.7 to 88.8
|
74.3 Percentage of Participants
Interval 67.7 to 80.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 17F
|
66.1 Percentage of Participants
Interval 58.8 to 72.9
|
62.6 Percentage of Participants
Interval 55.3 to 69.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 19A
|
58.1 Percentage of Participants
Interval 51.2 to 64.7
|
61.0 Percentage of Participants
Interval 54.1 to 67.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 20A
|
54.1 Percentage of Participants
Interval 47.1 to 61.1
|
42.3 Percentage of Participants
Interval 35.3 to 49.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 22F
|
62.0 Percentage of Participants
Interval 55.0 to 68.6
|
52.3 Percentage of Participants
Interval 45.1 to 59.4
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 33F
|
58.0 Percentage of Participants
Interval 51.1 to 64.7
|
63.7 Percentage of Participants
Interval 56.9 to 70.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 6A
|
72.8 Percentage of Participants
Interval 65.8 to 79.1
|
45.3 Percentage of Participants
Interval 38.0 to 52.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 15A
|
59.7 Percentage of Participants
Interval 52.1 to 66.9
|
26.0 Percentage of Participants
Interval 19.6 to 33.3
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 15C
|
81.0 Percentage of Participants
Interval 74.9 to 86.2
|
65.4 Percentage of Participants
Interval 58.2 to 72.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 16F
|
50.3 Percentage of Participants
Interval 43.1 to 57.4
|
11.9 Percentage of Participants
Interval 7.8 to 17.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 23A
|
57.6 Percentage of Participants
Interval 49.1 to 65.8
|
27.9 Percentage of Participants
Interval 19.8 to 37.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 23B
|
82.1 Percentage of Participants
Interval 76.1 to 87.1
|
43.7 Percentage of Participants
Interval 36.7 to 50.9
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 24F
|
42.9 Percentage of Participants
Interval 35.9 to 50.1
|
16.0 Percentage of Participants
Interval 10.9 to 22.3
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 31
|
70.3 Percentage of Participants
Interval 63.8 to 76.3
|
13.1 Percentage of Participants
Interval 8.9 to 18.4
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 35B
|
52.9 Percentage of Participants
Interval 46.1 to 59.7
|
6.0 Percentage of Participants
Interval 3.2 to 10.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 6C
|
34.2 Percentage of Participants
Interval 27.6 to 41.1
|
25.4 Percentage of Participants
Interval 19.5 to 32.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Serotype 15B
|
67.2 Percentage of Participants
Interval 60.0 to 73.9
|
54.6 Percentage of Participants
Interval 47.1 to 61.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: The analysis population consists of all randomized participants without deviations from the protocol that may substantially affect this outcome measure's results, and who had data for both time points.
Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V116
n=225 Participants
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 Participants
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 15B
|
60.4 Percentage of Participants
Interval 53.7 to 66.9
|
65.3 Percentage of Participants
Interval 58.7 to 71.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 3
|
56.4 Percentage of Participants
Interval 49.7 to 63.0
|
59.6 Percentage of Participants
Interval 52.8 to 66.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 7F
|
77.8 Percentage of Participants
Interval 71.8 to 83.0
|
70.7 Percentage of Participants
Interval 64.2 to 76.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 8
|
78.7 Percentage of Participants
Interval 72.7 to 83.8
|
78.7 Percentage of Participants
Interval 72.7 to 83.8
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 9N
|
72.9 Percentage of Participants
Interval 66.6 to 78.6
|
75.1 Percentage of Participants
Interval 68.9 to 80.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 10A
|
79.1 Percentage of Participants
Interval 73.2 to 84.2
|
61.8 Percentage of Participants
Interval 55.1 to 68.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 11A
|
69.3 Percentage of Participants
Interval 62.9 to 75.3
|
44.9 Percentage of Participants
Interval 38.3 to 51.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 12F
|
73.3 Percentage of Participants
Interval 67.0 to 79.0
|
56.9 Percentage of Participants
Interval 50.1 to 63.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 17F
|
82.7 Percentage of Participants
Interval 77.1 to 87.4
|
69.3 Percentage of Participants
Interval 62.9 to 75.3
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 19A
|
49.3 Percentage of Participants
Interval 42.6 to 56.1
|
47.1 Percentage of Participants
Interval 40.4 to 53.9
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 20A
|
75.1 Percentage of Participants
Interval 68.9 to 80.6
|
59.6 Percentage of Participants
Interval 52.8 to 66.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 22F
|
71.6 Percentage of Participants
Interval 65.2 to 77.4
|
56.9 Percentage of Participants
Interval 50.1 to 63.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 33F
|
71.6 Percentage of Participants
Interval 65.2 to 77.4
|
73.3 Percentage of Participants
Interval 67.0 to 79.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 6A
|
76.4 Percentage of Participants
Interval 70.3 to 81.8
|
45.8 Percentage of Participants
Interval 39.1 to 52.5
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 15A
|
80.9 Percentage of Participants
Interval 75.1 to 85.8
|
27.6 Percentage of Participants
Interval 21.8 to 33.9
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 15C
|
77.8 Percentage of Participants
Interval 71.8 to 83.0
|
61.3 Percentage of Participants
Interval 54.6 to 67.7
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 16F
|
80.4 Percentage of Participants
Interval 74.7 to 85.4
|
8.0 Percentage of Participants
Interval 4.8 to 12.4
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 23A
|
76.9 Percentage of Participants
Interval 70.8 to 82.2
|
14.7 Percentage of Participants
Interval 10.3 to 20.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 23B
|
72.9 Percentage of Participants
Interval 66.6 to 78.6
|
35.6 Percentage of Participants
Interval 29.3 to 42.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 24F
|
87.6 Percentage of Participants
Interval 82.5 to 91.6
|
0.0 Percentage of Participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 31
|
75.6 Percentage of Participants
Interval 69.4 to 81.0
|
7.6 Percentage of Participants
Interval 4.5 to 11.8
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 35B
|
84.0 Percentage of Participants
Interval 78.5 to 88.5
|
0.9 Percentage of Participants
Interval 0.1 to 3.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Serotype 6C
|
29.8 Percentage of Participants
Interval 23.9 to 36.2
|
6.7 Percentage of Participants
Interval 3.8 to 10.8
|
Adverse Events
V116
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
PPSV23
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V116
n=225 participants at risk
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 participants at risk
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
Nervous system disorders
Lacunar infarction
|
0.44%
1/225 • Number of events 1 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
0.00%
0/225 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
Other adverse events
| Measure |
V116
n=225 participants at risk
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
|
PPSV23
n=225 participants at risk
Participants receive a single IM injection of PPSV23 on Day 1.
|
|---|---|---|
|
General disorders
Injection site pain
|
26.7%
60/225 • Number of events 60 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
36.0%
81/225 • Number of events 82 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
|
General disorders
Injection site erythema
|
8.4%
19/225 • Number of events 19 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
10.7%
24/225 • Number of events 24 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
|
General disorders
Fatigue
|
6.7%
15/225 • Number of events 15 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
11.1%
25/225 • Number of events 25 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
|
General disorders
Injection site swelling
|
6.2%
14/225 • Number of events 14 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
7.6%
17/225 • Number of events 17 • Up to approximately 30 days
All participants who received at least 1 dose of study intervention are included.
|
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