Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6) (NCT NCT05420961)
NCT ID: NCT05420961
Last Updated: 2024-10-26
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
717 participants
Primary outcome timeframe
Up to 5 days post-vaccination
Results posted on
2024-10-26
Participant Flow
717 adults were randomized to 1 of 3 cohorts. One participant randomized to receive PCV15 in Cohort 1 incorrectly received V116. Per protocol the participant was included in the Cohort 1 V116 group. One participant randomized to receive PCV15 in Cohort 1 incorrectly received PPSV23 (intervention for Cohort 2). Per protocol this participant was excluded from the all participants as treated population because the actual intervention received was not 1 of the 2 designated interventions in Cohort 1.
Participant milestones
| Measure |
Cohort 1: V116
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
231
|
119
|
176
|
85
|
106
|
|
Overall Study
Day 1 - Vaccinated With V116
|
229
|
1
|
174
|
0
|
105
|
|
Overall Study
Day 1 - Vaccinated With PCV15
|
0
|
117
|
0
|
0
|
0
|
|
Overall Study
Day 1 - Vaccinated With PPSV23
|
0
|
1
|
0
|
85
|
0
|
|
Overall Study
COMPLETED
|
229
|
118
|
173
|
85
|
105
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: V116
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Randomized by mistake without study treatment
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Baseline characteristics by cohort
| Measure |
Cohort 1: V116
n=231 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=119 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=176 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=106 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
Total
n=717 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.8 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
69.0 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
65.4 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
65.4 Years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
71.0 Years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
67.9 Years
STANDARD_DEVIATION 7.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
383 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
334 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
207 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
612 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
236 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
127 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
459 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days post-vaccinationPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Outcome measures
| Measure |
Cohort 1: V116
n=230 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=174 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=105 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site swelling
|
8.3 Percentage of Participants
|
8.5 Percentage of Participants
|
4.6 Percentage of Participants
|
16.5 Percentage of Participants
|
10.5 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site erythema
|
7.4 Percentage of Participants
|
7.7 Percentage of Participants
|
7.5 Percentage of Participants
|
9.4 Percentage of Participants
|
7.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Injection site pain
|
35.7 Percentage of Participants
|
43.6 Percentage of Participants
|
41.4 Percentage of Participants
|
47.1 Percentage of Participants
|
43.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 5 days post-vaccinationPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Outcome measures
| Measure |
Cohort 1: V116
n=230 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=174 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=105 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs
Fatigue
|
14.3 Percentage of Participants
|
17.1 Percentage of Participants
|
19.0 Percentage of Participants
|
12.9 Percentage of Participants
|
21.9 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic AEs
Headache
|
7.0 Percentage of Participants
|
9.4 Percentage of Participants
|
10.3 Percentage of Participants
|
11.8 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic AEs
Myalgia
|
7.4 Percentage of Participants
|
2.6 Percentage of Participants
|
9.8 Percentage of Participants
|
9.4 Percentage of Participants
|
8.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic AEs
Pyrexia
|
1.7 Percentage of Participants
|
2.6 Percentage of Participants
|
2.9 Percentage of Participants
|
1.2 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to ~180 daysPopulation: All randomized participants who received at least 1 dose of study vaccination were analyzed.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=230 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=174 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=105 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: 30 Days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=215 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=115 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=166 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=78 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=99 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 6A
|
1653.5 Titers
Interval 1347.2 to 2029.4
|
2076.1 Titers
Interval 1571.4 to 2742.8
|
3624.0 Titers
Interval 3099.2 to 4237.7
|
1812.3 Titers
Interval 1226.6 to 2677.6
|
2097.3 Titers
Interval 1693.4 to 2597.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 7F
|
2184.4 Titers
Interval 1891.4 to 2522.8
|
1750.3 Titers
Interval 1404.7 to 2181.0
|
3129.8 Titers
Interval 2609.9 to 3753.3
|
4057.0 Titers
Interval 3211.2 to 5125.6
|
2051.3 Titers
Interval 1630.2 to 2581.0
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 3
|
262.1 Titers
Interval 224.0 to 306.8
|
226.3 Titers
Interval 182.0 to 281.4
|
391.1 Titers
Interval 332.8 to 459.6
|
583.1 Titers
Interval 453.5 to 749.6
|
318.3 Titers
Interval 250.0 to 405.3
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 19A
|
1513.8 Titers
Interval 1318.4 to 1738.1
|
2022.9 Titers
Interval 1634.1 to 2504.3
|
2528.9 Titers
Interval 2201.7 to 2904.9
|
3241.5 Titers
Interval 2646.0 to 3971.0
|
1533.8 Titers
Interval 1272.4 to 1848.9
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 22F
|
1983.8 Titers
Interval 1698.3 to 2317.4
|
1595.6 Titers
Interval 1227.1 to 2074.6
|
4389.2 Titers
Interval 3541.1 to 5440.3
|
2524.0 Titers
Interval 1834.5 to 3472.5
|
1913.5 Titers
Interval 1453.5 to 2519.0
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 33F
|
4311.9 Titers
Interval 3625.1 to 5128.9
|
3397.2 Titers
Interval 2665.3 to 4330.0
|
8162.9 Titers
Interval 6407.2 to 10399.7
|
8761.9 Titers
Interval 6157.4 to 12468.1
|
4654.3 Titers
Interval 3532.1 to 6133.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 8
|
1273.0 Titers
Interval 1115.1 to 1453.3
|
345.8 Titers
Interval 250.5 to 477.5
|
2320.1 Titers
Interval 1987.3 to 2708.7
|
2723.2 Titers
Interval 2197.4 to 3374.8
|
1486.8 Titers
Interval 1230.5 to 1796.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 9N
|
3805.1 Titers
Interval 3324.0 to 4356.0
|
2176.5 Titers
Interval 1809.6 to 2617.9
|
7214.4 Titers
Interval 6062.9 to 8584.6
|
6482.5 Titers
Interval 4908.9 to 8560.7
|
4054.5 Titers
Interval 3389.4 to 4850.2
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 10A
|
1986.2 Titers
Interval 1637.7 to 2408.9
|
467.5 Titers
Interval 337.0 to 648.5
|
3976.8 Titers
Interval 3360.7 to 4705.8
|
1797.6 Titers
Interval 1136.2 to 2843.9
|
2564.0 Titers
Interval 1959.1 to 3355.6
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 11A
|
1998.5 Titers
Interval 1696.9 to 2353.8
|
335.6 Titers
Interval 228.9 to 491.8
|
2846.6 Titers
Interval 2411.0 to 3360.8
|
1736.6 Titers
Interval 1367.1 to 2206.1
|
2373.0 Titers
Interval 1905.4 to 2955.4
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 12F
|
981.8 Titers
Interval 782.4 to 1232.1
|
80.5 Titers
Interval 54.0 to 120.1
|
2252.6 Titers
Interval 2120.5 to 3072.9
|
1402.5 Titers
Interval 912.2 to 2156.4
|
1235.3 Titers
Interval 948.3 to 1609.2
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 15A
|
4184.9 Titers
Interval 3548.3 to 4935.6
|
877.2 Titers
Interval 616.2 to 1248.7
|
6185.2 Titers
Interval 5179.3 to 7386.6
|
1668.2 Titers
Interval 1234.4 to 2254.5
|
4328.6 Titers
Interval 3378.7 to 5545.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 15C
|
2307.8 Titers
Interval 1878.4 to 2835.4
|
539.6 Titers
Interval 371.1 to 784.6
|
4334.4 Titers
Interval 3563.8 to 5271.5
|
1470.4 Titers
Interval 978.6 to 2209.3
|
2191.9 Titers
Interval 1573.2 to 3053.9
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 16F
|
3060.5 Titers
Interval 2633.8 to 3556.3
|
392.3 Titers
Interval 301.3 to 510.8
|
4626.5 Titers
Interval 3861.8 to 5542.6
|
832.8 Titers
Interval 604.3 to 1147.6
|
2477.0 Titers
Interval 1887.2 to 3251.2
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 17F
|
3599.8 Titers
Interval 3134.5 to 4134.3
|
939.6 Titers
Interval 693.7 to 1272.6
|
5963.8 Titers
Interval 5036.6 to 7061.7
|
4367.3 Titers
Interval 3372.5 to 5655.7
|
3836.7 Titers
Interval 3063.4 to 4805.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 20A
|
2847.4 Titers
Interval 2433.3 to 3331.8
|
1058.9 Titers
Interval 829.9 to 1351.1
|
6005.5 Titers
Interval 4919.8 to 7330.8
|
3393.9 Titers
Interval 2536.9 to 4540.5
|
2433.4 Titers
Interval 1880.5 to 3148.9
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 23A
|
2363.9 Titers
Interval 1857.4 to 3008.5
|
310.2 Titers
Interval 202.1 to 476.0
|
4253.4 Titers
Interval 3417.6 to 5293.5
|
433.6 Titers
Interval 247.5 to 759.5
|
3967.2 Titers
Interval 2764.8 to 5692.7
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 23B
|
673.2 Titers
Interval 517.1 to 876.4
|
153.0 Titers
Interval 98.7 to 237.1
|
1530.7 Titers
Interval 1196.5 to 1958.3
|
203.9 Titers
Interval 127.6 to 325.6
|
844.0 Titers
Interval 608.2 to 1171.4
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 24F
|
1822.6 Titers
Interval 1411.6 to 2353.3
|
106.6 Titers
Interval 69.7 to 162.9
|
2746.1 Titers
Interval 2257.9 to 3339.9
|
48.5 Titers
Interval 28.6 to 82.1
|
2041.5 Titers
Interval 1500.8 to 2777.1
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 31
|
3018.4 Titers
Interval 2473.6 to 3683.3
|
113.2 Titers
Interval 74.5 to 172.1
|
4413.5 Titers
Interval 3530.2 to 5517.7
|
171.8 Titers
Interval 99.9 to 295.6
|
3285.5 Titers
Interval 2485.0 to 4343.8
|
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 35B
|
6703.1 Titers
Interval 5732.7 to 7837.8
|
1019.1 Titers
Interval 739.9 to 1403.7
|
8143.5 Titers
Interval 6761.4 to 9808.1
|
1527.7 Titers
Interval 1169.5 to 1995.5
|
5836.8 Titers
Interval 4693.6 to 7258.6
|
SECONDARY outcome
Timeframe: 30 Days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=220 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=167 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=81 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=99 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 3
|
0.87 μg/mL
Interval 0.77 to 0.99
|
0.80 μg/mL
Interval 0.65 to 0.97
|
0.89 μg/mL
Interval 0.77 to 1.03
|
1.58 μg/mL
Interval 1.25 to 2.0
|
0.85 μg/mL
Interval 0.7 to 1.03
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6A
|
4.69 μg/mL
Interval 3.72 to 5.9
|
7.69 μg/mL
Interval 5.6 to 10.57
|
7.81 μg/mL
Interval 6.3 to 9.68
|
5.24 μg/mL
Interval 3.62 to 7.56
|
5.48 μg/mL
Interval 4.27 to 7.03
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 7F
|
5.71 μg/mL
Interval 4.89 to 6.68
|
6.45 μg/mL
Interval 5.08 to 8.19
|
5.65 μg/mL
Interval 4.75 to 6.73
|
8.34 μg/mL
Interval 6.57 to 10.59
|
5.07 μg/mL
Interval 4.12 to 6.23
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19A
|
8.54 μg/mL
Interval 7.33 to 9.95
|
11.97 μg/mL
Interval 9.4 to 15.24
|
9.12 μg/mL
Interval 7.7 to 10.81
|
12.41 μg/mL
Interval 9.57 to 16.11
|
8.06 μg/mL
Interval 6.5 to 9.98
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 22F
|
4.41 μg/mL
Interval 3.69 to 5.28
|
4.33 μg/mL
Interval 3.37 to 5.56
|
5.38 μg/mL
Interval 4.34 to 6.66
|
2.87 μg/mL
Interval 2.12 to 3.87
|
3.08 μg/mL
Interval 2.36 to 4.01
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 33F
|
13.36 μg/mL
Interval 11.22 to 15.91
|
12.72 μg/mL
Interval 10.37 to 15.61
|
15.04 μg/mL
Interval 12.31 to 18.37
|
13.92 μg/mL
Interval 10.23 to 18.94
|
9.66 μg/mL
Interval 7.53 to 12.4
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 8
|
9.58 μg/mL
Interval 8.21 to 11.17
|
3.56 μg/mL
Interval 2.74 to 4.62
|
11.29 μg/mL
Interval 9.28 to 13.73
|
14.47 μg/mL
Interval 10.86 to 19.27
|
7.48 μg/mL
Interval 5.87 to 9.53
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 9N
|
7.06 μg/mL
Interval 5.92 to 8.43
|
3.59 μg/mL
Interval 2.83 to 4.55
|
8.48 μg/mL
Interval 6.89 to 10.44
|
7.32 μg/mL
Interval 5.47 to 9.78
|
4.15 μg/mL
Interval 3.23 to 5.34
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 10A
|
9.86 μg/mL
Interval 7.99 to 12.18
|
2.77 μg/mL
Interval 2.12 to 3.63
|
18.21 μg/mL
Interval 14.3 to 23.18
|
7.29 μg/mL
Interval 4.94 to 10.74
|
10.03 μg/mL
Interval 7.21 to 13.98
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 11A
|
7.16 μg/mL
Interval 6.09 to 8.42
|
2.06 μg/mL
Interval 1.65 to 2.58
|
9.13 μg/mL
Interval 7.44 to 11.22
|
3.95 μg/mL
Interval 2.98 to 5.23
|
4.78 μg/mL
Interval 3.79 to 6.03
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 12F
|
1.46 μg/mL
Interval 1.18 to 1.81
|
0.41 μg/mL
Interval 0.3 to 0.55
|
1.91 μg/mL
Interval 1.44 to 2.53
|
1.01 μg/mL
Interval 0.65 to 1.56
|
0.96 μg/mL
Interval 0.7 to 1.31
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 15A
|
16.35 μg/mL
Interval 13.45 to 19.88
|
1.56 μg/mL
Interval 1.19 to 2.05
|
20.24 μg/mL
Interval 15.92 to 25.75
|
2.15 μg/mL
Interval 1.52 to 3.03
|
11.16 μg/mL
Interval 7.91 to 15.75
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 15C
|
11.08 μg/mL
Interval 9.01 to 13.62
|
3.25 μg/mL
Interval 2.37 to 4.45
|
16.67 μg/mL
Interval 12.78 to 21.76
|
4.31 μg/mL
Interval 2.91 to 6.38
|
6.51 μg/mL
Interval 4.72 to 8.99
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 16F
|
4.69 μg/mL
Interval 3.75 to 5.87
|
0.37 μg/mL
Interval 0.28 to 0.48
|
4.04 μg/mL
Interval 3.19 to 5.1
|
0.30 μg/mL
Interval 0.22 to 0.41
|
2.46 μg/mL
Interval 1.78 to 3.41
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 17F
|
13.20 μg/mL
Interval 11.18 to 15.58
|
2.68 μg/mL
Interval 2.08 to 3.46
|
14.96 μg/mL
Interval 12.37 to 18.08
|
7.23 μg/mL
Interval 5.26 to 9.92
|
9.92 μg/mL
Interval 7.86 to 12.53
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 20A
|
14.83 μg/mL
Interval 12.37 to 17.77
|
4.93 μg/mL
Interval 3.83 to 6.36
|
22.21 μg/mL
Interval 17.77 to 27.75
|
10.73 μg/mL
Interval 7.48 to 15.41
|
12.16 μg/mL
Interval 8.99 to 16.46
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23A
|
5.38 μg/mL
Interval 4.19 to 6.9
|
0.75 μg/mL
Interval 0.55 to 1.02
|
6.03 μg/mL
Interval 4.55 to 7.99
|
0.62 μg/mL
Interval 0.43 to 0.9
|
4.25 μg/mL
Interval 2.88 to 6.26
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23B
|
6.66 μg/mL
Interval 5.53 to 8.03
|
2.61 μg/mL
Interval 1.96 to 3.48
|
6.00 μg/mL
Interval 4.91 to 7.33
|
2.31 μg/mL
Interval 1.75 to 3.06
|
5.05 μg/mL
Interval 3.9 to 6.54
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 24F
|
10.05 μg/mL
Interval 7.59 to 13.32
|
0.49 μg/mL
Interval 0.39 to 0.61
|
7.48 μg/mL
Interval 5.45 to 10.46
|
0.31 μg/mL
Interval 0.23 to 0.42
|
6.12 μg/mL
Interval 3.84 to 9.75
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 31
|
4.48 μg/mL
Interval 3.66 to 5.48
|
0.37 μg/mL
Interval 0.3 to 0.47
|
3.58 μg/mL
Interval 2.87 to 4.46
|
0.32 μg/mL
Interval 0.24 to 0.44
|
3.66 μg/mL
Interval 2.64 to 5.08
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Serotype 35B
|
26.31 μg/mL
Interval 21.6 to 32.04
|
1.45 μg/mL
Interval 1.18 to 1.78
|
24.55 μg/mL
Interval 20.09 to 30.01
|
1.45 μg/mL
Interval 1.17 to 1.8
|
18.15 μg/mL
Interval 13.61 to 24.21
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and 30 days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=212 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=115 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=164 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=76 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=98 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 3
|
4.4 Ratio
Interval 3.7 to 5.3
|
4.0 Ratio
Interval 3.1 to 5.3
|
6.2 Ratio
Interval 5.0 to 7.6
|
7.5 Ratio
Interval 5.3 to 10.5
|
5.0 Ratio
Interval 3.6 to 7.0
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 6A
|
6.2 Ratio
Interval 5.0 to 7.7
|
7.1 Ratio
Interval 4.9 to 10.3
|
4.2 Ratio
Interval 3.3 to 5.3
|
1.8 Ratio
Interval 1.4 to 2.4
|
5.5 Ratio
Interval 4.1 to 7.4
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 7F
|
4.1 Ratio
Interval 3.3 to 5.1
|
3.9 Ratio
Interval 2.8 to 5.4
|
4.6 Ratio
Interval 3.6 to 5.9
|
4.2 Ratio
Interval 3.1 to 5.8
|
3.9 Ratio
Interval 2.9 to 5.3
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 19A
|
2.4 Ratio
Interval 2.0 to 2.8
|
3.3 Ratio
Interval 2.5 to 4.4
|
2.8 Ratio
Interval 2.3 to 3.3
|
3.6 Ratio
Interval 2.7 to 4.7
|
2.5 Ratio
Interval 1.8 to 3.3
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 22F
|
7.0 Ratio
Interval 5.5 to 9.0
|
7.1 Ratio
Interval 4.8 to 10.6
|
26.3 Ratio
Interval 17.7 to 39.2
|
14.8 Ratio
Interval 8.7 to 25.1
|
7.5 Ratio
Interval 4.9 to 11.4
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 33F
|
2.2 Ratio
Interval 1.8 to 2.6
|
1.7 Ratio
Interval 1.3 to 2.4
|
6.3 Ratio
Interval 4.8 to 8.4
|
9.2 Ratio
Interval 5.6 to 15.3
|
2.7 Ratio
Interval 2.0 to 3.7
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 8
|
2.8 Ratio
Interval 2.4 to 3.4
|
0.9 Ratio
Interval 0.7 to 1.0
|
16.6 Ratio
Interval 12.2 to 22.7
|
18.6 Ratio
Interval 11.9 to 29.1
|
3.8 Ratio
Interval 2.7 to 5.3
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 9N
|
2.3 Ratio
Interval 2.0 to 2.7
|
1.4 Ratio
Interval 1.1 to 1.7
|
5.9 Ratio
Interval 4.7 to 7.4
|
6.8 Ratio
Interval 4.7 to 9.8
|
3.5 Ratio
Interval 2.7 to 4.5
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 10A
|
4.3 Ratio
Interval 3.5 to 5.4
|
1.0 Ratio
Interval 0.9 to 1.2
|
17.1 Ratio
Interval 12.7 to 23.0
|
11.8 Ratio
Interval 7.5 to 18.6
|
4.7 Ratio
Interval 3.4 to 6.5
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 11A
|
6.5 Ratio
Interval 5.2 to 8.2
|
1.2 Ratio
Interval 0.9 to 1.7
|
21.0 Ratio
Interval 14.6 to 30.4
|
9.2 Ratio
Interval 5.9 to 14.4
|
9.5 Ratio
Interval 6.2 to 14.4
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 12F
|
11.8 Ratio
Interval 9.0 to 15.4
|
1.1 Ratio
Interval 1.0 to 1.3
|
82.2 Ratio
Interval 62.9 to 107.4
|
41.9 Ratio
Interval 26.1 to 67.2
|
13.7 Ratio
Interval 9.0 to 20.8
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 15A
|
5.6 Ratio
Interval 4.3 to 7.4
|
1.2 Ratio
Interval 0.9 to 1.5
|
9.0 Ratio
Interval 6.8 to 11.8
|
3.0 Ratio
Interval 2.0 to 4.5
|
7.2 Ratio
Interval 4.6 to 11.2
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 15C
|
8.5 Ratio
Interval 6.7 to 10.9
|
1.3 Ratio
Interval 1.0 to 1.7
|
30.6 Ratio
Interval 22.5 to 41.5
|
12.7 Ratio
Interval 8.5 to 18.8
|
11.6 Ratio
Interval 8.1 to 16.4
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 16F
|
7.1 Ratio
Interval 5.9 to 8.5
|
1.1 Ratio
Interval 0.9 to 1.3
|
9.8 Ratio
Interval 7.8 to 12.4
|
2.0 Ratio
Interval 1.5 to 2.7
|
7.2 Ratio
Interval 5.5 to 9.6
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 17F
|
3.7 Ratio
Interval 3.0 to 4.5
|
0.9 Ratio
Interval 0.8 to 1.1
|
13.5 Ratio
Interval 9.5 to 19.2
|
8.1 Ratio
Interval 5.6 to 11.7
|
6.5 Ratio
Interval 4.6 to 9.3
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 20A
|
3.7 Ratio
Interval 3.0 to 4.5
|
0.9 Ratio
Interval 0.8 to 1.0
|
12.2 Ratio
Interval 9.3 to 16.0
|
6.0 Ratio
Interval 4.4 to 8.3
|
4.4 Ratio
Interval 3.1 to 6.1
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 23A
|
8.4 Ratio
Interval 6.2 to 11.6
|
1.4 Ratio
Interval 1.0 to 1.9
|
19.0 Ratio
Interval 13.5 to 26.9
|
2.5 Ratio
Interval 1.3 to 4.9
|
16.3 Ratio
Interval 10.3 to 25.7
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 23B
|
21.4 Ratio
Interval 16.2 to 28.1
|
4.2 Ratio
Interval 2.9 to 6.0
|
35.5 Ratio
Interval 25.9 to 48.6
|
5.2 Ratio
Interval 3.5 to 7.6
|
26.1 Ratio
Interval 17.5 to 38.9
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 24F
|
25.8 Ratio
Interval 19.5 to 34.0
|
1.0 Ratio
Interval 0.8 to 1.3
|
31.1 Ratio
Interval 22.8 to 42.6
|
0.9 Ratio
Interval 0.7 to 1.3
|
39.5 Ratio
Interval 27.4 to 56.9
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 31
|
16.7 Ratio
Interval 12.5 to 22.3
|
0.9 Ratio
Interval 0.7 to 1.2
|
35.6 Ratio
Interval 24.8 to 51.2
|
1.7 Ratio
Interval 1.1 to 2.6
|
30.5 Ratio
Interval 19.1 to 48.6
|
|
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Serotype 35B
|
6.0 Ratio
Interval 4.8 to 7.4
|
1.0 Ratio
Interval 0.8 to 1.2
|
7.2 Ratio
Interval 5.6 to 9.2
|
1.4 Ratio
Interval 1.1 to 1.8
|
5.7 Ratio
Interval 4.2 to 7.9
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and 30 days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=212 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=115 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=164 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=76 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=98 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 3
|
54.9 Percentage of Participants
Interval 46.9 to 62.6
|
54.9 Percentage of Participants
Interval 44.2 to 65.4
|
64.1 Percentage of Participants
Interval 55.3 to 72.3
|
66.2 Percentage of Participants
Interval 53.7 to 77.2
|
48.7 Percentage of Participants
Interval 37.0 to 60.4
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 6A
|
57.9 Percentage of Participants
Interval 50.1 to 65.4
|
58.6 Percentage of Participants
Interval 47.6 to 69.1
|
46.3 Percentage of Participants
Interval 37.7 to 55.1
|
18.2 Percentage of Participants
Interval 9.8 to 29.6
|
56.2 Percentage of Participants
Interval 45.3 to 66.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 7F
|
38.5 Percentage of Participants
Interval 31.7 to 45.6
|
43.1 Percentage of Participants
Interval 33.4 to 53.3
|
44.5 Percentage of Participants
Interval 36.3 to 53.0
|
49.3 Percentage of Participants
Interval 37.0 to 61.6
|
38.0 Percentage of Participants
Interval 28.1 to 48.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 19A
|
28.4 Percentage of Participants
Interval 22.1 to 35.2
|
34.6 Percentage of Participants
Interval 25.6 to 44.6
|
33.6 Percentage of Participants
Interval 26.0 to 41.7
|
38.9 Percentage of Participants
Interval 27.6 to 51.1
|
30.0 Percentage of Participants
Interval 20.8 to 40.6
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 22F
|
53.9 Percentage of Participants
Interval 46.6 to 61.1
|
54.9 Percentage of Participants
Interval 44.7 to 64.8
|
77.4 Percentage of Participants
Interval 69.0 to 84.4
|
65.6 Percentage of Participants
Interval 52.7 to 77.1
|
50.0 Percentage of Participants
Interval 39.5 to 60.5
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 33F
|
19.8 Percentage of Participants
Interval 14.2 to 26.4
|
19.4 Percentage of Participants
Interval 11.9 to 28.9
|
52.0 Percentage of Participants
Interval 42.9 to 61.0
|
56.0 Percentage of Participants
Interval 41.3 to 70.0
|
29.4 Percentage of Participants
Interval 20.0 to 40.3
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 8
|
33.3 Percentage of Participants
Interval 26.8 to 40.4
|
2.8 Percentage of Participants
Interval 0.6 to 7.9
|
70.2 Percentage of Participants
Interval 62.2 to 77.4
|
74.6 Percentage of Participants
Interval 62.9 to 84.2
|
34.4 Percentage of Participants
Interval 25.0 to 44.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 9N
|
22.0 Percentage of Participants
Interval 16.3 to 28.7
|
6.5 Percentage of Participants
Interval 2.6 to 12.9
|
57.4 Percentage of Participants
Interval 48.6 to 65.8
|
67.9 Percentage of Participants
Interval 53.7 to 80.1
|
39.1 Percentage of Participants
Interval 28.8 to 50.1
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 10A
|
46.0 Percentage of Participants
Interval 38.9 to 53.2
|
2.7 Percentage of Participants
Interval 0.6 to 7.7
|
74.3 Percentage of Participants
Interval 66.5 to 81.1
|
67.6 Percentage of Participants
Interval 55.5 to 78.2
|
49.5 Percentage of Participants
Interval 38.9 to 60.0
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 11A
|
53.8 Percentage of Participants
Interval 46.3 to 61.1
|
12.1 Percentage of Participants
Interval 6.2 to 20.6
|
73.3 Percentage of Participants
Interval 64.8 to 80.6
|
53.8 Percentage of Participants
Interval 41.0 to 66.3
|
59.0 Percentage of Participants
Interval 47.7 to 69.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 12F
|
62.8 Percentage of Participants
Interval 55.8 to 69.4
|
6.3 Percentage of Participants
Interval 2.5 to 12.5
|
93.0 Percentage of Participants
Interval 87.8 to 96.5
|
81.9 Percentage of Participants
Interval 71.1 to 90.0
|
60.2 Percentage of Participants
Interval 49.5 to 70.2
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 15A
|
53.5 Percentage of Participants
Interval 45.0 to 61.9
|
12.8 Percentage of Participants
Interval 6.3 to 22.3
|
70.9 Percentage of Participants
Interval 61.5 to 79.2
|
35.0 Percentage of Participants
Interval 20.6 to 51.7
|
59.7 Percentage of Participants
Interval 46.4 to 71.9
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 15C
|
61.4 Percentage of Participants
Interval 54.2 to 68.3
|
10.2 Percentage of Participants
Interval 5.2 to 17.5
|
84.4 Percentage of Participants
Interval 77.3 to 90.0
|
72.1 Percentage of Participants
Interval 59.9 to 82.3
|
72.0 Percentage of Participants
Interval 60.9 to 81.3
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 16F
|
68.0 Percentage of Participants
Interval 60.5 to 74.9
|
8.0 Percentage of Participants
Interval 3.5 to 15.2
|
70.5 Percentage of Participants
Interval 61.9 to 78.1
|
30.9 Percentage of Participants
Interval 20.2 to 43.3
|
70.9 Percentage of Participants
Interval 60.1 to 80.2
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 17F
|
37.7 Percentage of Participants
Interval 30.7 to 45.2
|
2.0 Percentage of Participants
Interval 0.2 to 7.0
|
74.1 Percentage of Participants
Interval 65.2 to 81.8
|
62.5 Percentage of Participants
Interval 49.5 to 74.3
|
54.4 Percentage of Participants
Interval 42.8 to 65.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 20A
|
37.5 Percentage of Participants
Interval 30.5 to 44.9
|
2.9 Percentage of Participants
Interval 0.6 to 8.1
|
76.7 Percentage of Participants
Interval 68.5 to 83.7
|
60.9 Percentage of Participants
Interval 48.4 to 72.4
|
46.9 Percentage of Participants
Interval 35.7 to 58.3
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 23A
|
59.9 Percentage of Participants
Interval 51.8 to 67.6
|
21.1 Percentage of Participants
Interval 12.5 to 31.9
|
73.7 Percentage of Participants
Interval 64.8 to 81.4
|
34.2 Percentage of Participants
Interval 19.6 to 51.4
|
80.0 Percentage of Participants
Interval 68.2 to 88.9
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 23B
|
74.9 Percentage of Participants
Interval 68.1 to 80.9
|
40.4 Percentage of Participants
Interval 31.1 to 50.2
|
80.6 Percentage of Participants
Interval 73.5 to 86.5
|
43.7 Percentage of Participants
Interval 31.9 to 56.0
|
80.9 Percentage of Participants
Interval 71.4 to 88.2
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 24F
|
80.2 Percentage of Participants
Interval 73.8 to 85.7
|
7.7 Percentage of Participants
Interval 3.1 to 15.2
|
81.9 Percentage of Participants
Interval 74.1 to 88.2
|
4.9 Percentage of Participants
Interval 1.0 to 13.7
|
89.0 Percentage of Participants
Interval 80.2 to 94.9
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 31
|
70.9 Percentage of Participants
Interval 63.7 to 77.5
|
8.2 Percentage of Participants
Interval 3.6 to 15.6
|
81.3 Percentage of Participants
Interval 73.7 to 87.5
|
18.0 Percentage of Participants
Interval 9.4 to 30.0
|
82.1 Percentage of Participants
Interval 72.3 to 89.6
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Serotype 35B
|
55.2 Percentage of Participants
Interval 47.7 to 62.5
|
7.5 Percentage of Participants
Interval 3.3 to 14.3
|
65.3 Percentage of Participants
Interval 56.9 to 73.0
|
7.0 Percentage of Participants
Interval 2.3 to 15.7
|
57.6 Percentage of Participants
Interval 46.4 to 68.3
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and 30 days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=220 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=167 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=81 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=99 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 3
|
3.6 Ratio
Interval 3.2 to 4.0
|
3.1 Ratio
Interval 2.6 to 3.7
|
3.7 Ratio
Interval 3.2 to 4.3
|
5.7 Ratio
Interval 4.3 to 7.4
|
2.9 Ratio
Interval 2.3 to 3.5
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 6A
|
5.9 Ratio
Interval 5.0 to 7.1
|
8.0 Ratio
Interval 6.1 to 10.6
|
3.3 Ratio
Interval 2.7 to 4.0
|
2.5 Ratio
Interval 1.9 to 3.2
|
4.4 Ratio
Interval 3.4 to 5.7
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 7F
|
3.3 Ratio
Interval 2.8 to 3.8
|
2.9 Ratio
Interval 2.3 to 3.5
|
3.2 Ratio
Interval 2.7 to 3.8
|
3.2 Ratio
Interval 2.6 to 3.9
|
3.2 Ratio
Interval 2.6 to 4.0
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 19A
|
2.3 Ratio
Interval 2.0 to 2.7
|
3.4 Ratio
Interval 2.8 to 4.2
|
2.2 Ratio
Interval 1.9 to 2.5
|
3.0 Ratio
Interval 2.4 to 3.6
|
2.0 Ratio
Interval 1.7 to 2.4
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 22F
|
4.2 Ratio
Interval 3.6 to 4.9
|
3.4 Ratio
Interval 2.8 to 4.2
|
14.3 Ratio
Interval 11.4 to 18.0
|
8.5 Ratio
Interval 6.2 to 11.6
|
3.5 Ratio
Interval 2.7 to 4.6
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 33F
|
2.2 Ratio
Interval 1.9 to 2.5
|
1.8 Ratio
Interval 1.5 to 2.1
|
8.6 Ratio
Interval 7.1 to 10.5
|
10.5 Ratio
Interval 7.9 to 13.9
|
2.4 Ratio
Interval 1.9 to 3.0
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 8
|
2.7 Ratio
Interval 2.4 to 3.1
|
1.0 Ratio
Interval 0.9 to 1.1
|
12.1 Ratio
Interval 9.8 to 15.0
|
14.4 Ratio
Interval 10.3 to 20.0
|
2.3 Ratio
Interval 1.9 to 2.8
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 9N
|
2.9 Ratio
Interval 2.4 to 3.4
|
1.4 Ratio
Interval 1.2 to 1.6
|
8.7 Ratio
Interval 7.1 to 10.6
|
9.1 Ratio
Interval 6.8 to 12.1
|
3.2 Ratio
Interval 2.6 to 3.9
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 10A
|
4.4 Ratio
Interval 3.7 to 5.2
|
1.0 Ratio
Interval 0.9 to 1.0
|
18.9 Ratio
Interval 15.3 to 23.4
|
10.1 Ratio
Interval 7.6 to 13.4
|
4.2 Ratio
Interval 3.1 to 5.5
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 11A
|
4.1 Ratio
Interval 3.6 to 4.7
|
1.0 Ratio
Interval 0.9 to 1.0
|
10.3 Ratio
Interval 8.5 to 12.6
|
5.6 Ratio
Interval 4.4 to 7.2
|
3.5 Ratio
Interval 2.7 to 4.3
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 12F
|
4.2 Ratio
Interval 3.6 to 5.0
|
1.0 Ratio
Interval 0.9 to 1.1
|
14.2 Ratio
Interval 11.3 to 17.9
|
8.4 Ratio
Interval 5.8 to 12.0
|
3.5 Ratio
Interval 2.7 to 4.5
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 15A
|
12.2 Ratio
Interval 10.1 to 14.7
|
1.0 Ratio
Interval 0.9 to 1.1
|
24.5 Ratio
Interval 19.7 to 30.3
|
2.4 Ratio
Interval 2.0 to 3.0
|
16.6 Ratio
Interval 12.0 to 22.9
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 15C
|
5.8 Ratio
Interval 4.9 to 6.9
|
1.0 Ratio
Interval 0.9 to 1.2
|
18.8 Ratio
Interval 14.9 to 23.8
|
6.2 Ratio
Interval 4.8 to 8.2
|
6.4 Ratio
Interval 5.0 to 8.1
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 16F
|
15.2 Ratio
Interval 12.7 to 18.2
|
1.1 Ratio
Interval 1.0 to 1.2
|
15.7 Ratio
Interval 12.9 to 19.0
|
1.6 Ratio
Interval 1.3 to 1.8
|
11.9 Ratio
Interval 9.2 to 15.4
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 17F
|
4.7 Ratio
Interval 4.0 to 5.5
|
1.0 Ratio
Interval 0.9 to 1.1
|
17.4 Ratio
Interval 14.3 to 21.1
|
10.5 Ratio
Interval 7.8 to 14.1
|
3.8 Ratio
Interval 2.9 to 5.0
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 20A
|
3.8 Ratio
Interval 3.3 to 4.4
|
1.0 Ratio
Interval 0.9 to 1.1
|
14.8 Ratio
Interval 12.2 to 17.9
|
8.5 Ratio
Interval 6.4 to 11.4
|
3.7 Ratio
Interval 2.9 to 4.8
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 23A
|
13.5 Ratio
Interval 11.1 to 16.5
|
1.8 Ratio
Interval 1.5 to 2.2
|
18.9 Ratio
Interval 15.3 to 23.4
|
2.3 Ratio
Interval 1.9 to 2.7
|
13.1 Ratio
Interval 9.6 to 17.7
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 23B
|
8.2 Ratio
Interval 6.7 to 10.0
|
2.7 Ratio
Interval 2.1 to 3.5
|
7.3 Ratio
Interval 6.0 to 8.9
|
2.3 Ratio
Interval 1.9 to 2.9
|
7.3 Ratio
Interval 5.4 to 9.7
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 24F
|
26.9 Ratio
Interval 21.8 to 33.1
|
1.0 Ratio
Interval 0.9 to 1.1
|
21.7 Ratio
Interval 17.3 to 27.2
|
1.0 Ratio
Interval 0.9 to 1.1
|
24.4 Ratio
Interval 17.1 to 34.9
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 31
|
13.1 Ratio
Interval 11.0 to 15.6
|
1.1 Ratio
Interval 1.0 to 1.2
|
14.4 Ratio
Interval 11.9 to 17.3
|
1.5 Ratio
Interval 1.3 to 1.8
|
13.0 Ratio
Interval 9.9 to 17.0
|
|
Geometric Mean Fold Rise of Serotype-specific IgG
Serotype 35B
|
16.8 Ratio
Interval 13.9 to 20.3
|
1.0 Ratio
Interval 0.9 to 1.0
|
15.6 Ratio
Interval 12.9 to 18.7
|
0.9 Ratio
Interval 0.9 to 1.0
|
15.7 Ratio
Interval 11.9 to 20.8
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and 30 days post-vaccinationPopulation: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Outcome measures
| Measure |
Cohort 1: V116
n=220 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 Participants
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=167 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=81 Participants
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=99 Participants
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 20A
|
36.5 Percentage of Participants
Interval 30.1 to 43.3
|
0.9 Percentage of Participants
Interval 0.0 to 4.7
|
83.2 Percentage of Participants
Interval 76.7 to 88.6
|
69.1 Percentage of Participants
Interval 57.9 to 78.9
|
49.5 Percentage of Participants
Interval 39.3 to 59.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 23A
|
77.6 Percentage of Participants
Interval 71.5 to 83.0
|
17.1 Percentage of Participants
Interval 10.8 to 25.2
|
86.7 Percentage of Participants
Interval 80.6 to 91.5
|
21.0 Percentage of Participants
Interval 12.7 to 31.5
|
77.8 Percentage of Participants
Interval 68.3 to 85.5
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 3
|
42.7 Percentage of Participants
Interval 36.1 to 49.6
|
36.8 Percentage of Participants
Interval 28.0 to 46.2
|
40.7 Percentage of Participants
Interval 33.2 to 48.6
|
54.3 Percentage of Participants
Interval 42.9 to 65.4
|
35.4 Percentage of Participants
Interval 26.0 to 45.6
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 6A
|
56.2 Percentage of Participants
Interval 49.3 to 62.8
|
65.0 Percentage of Participants
Interval 55.6 to 73.5
|
35.9 Percentage of Participants
Interval 28.7 to 43.7
|
27.2 Percentage of Participants
Interval 17.9 to 38.2
|
45.5 Percentage of Participants
Interval 35.4 to 55.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 7F
|
34.7 Percentage of Participants
Interval 28.4 to 41.4
|
29.9 Percentage of Participants
Interval 21.8 to 39.1
|
37.7 Percentage of Participants
Interval 30.4 to 45.5
|
33.3 Percentage of Participants
Interval 23.2 to 44.7
|
37.4 Percentage of Participants
Interval 27.9 to 47.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 19A
|
24.7 Percentage of Participants
Interval 19.1 to 30.9
|
37.6 Percentage of Participants
Interval 28.8 to 47.0
|
19.8 Percentage of Participants
Interval 14.0 to 26.6
|
33.3 Percentage of Participants
Interval 23.2 to 44.7
|
19.2 Percentage of Participants
Interval 12.0 to 28.3
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 22F
|
39.3 Percentage of Participants
Interval 32.8 to 46.1
|
35.0 Percentage of Participants
Interval 26.5 to 44.4
|
78.4 Percentage of Participants
Interval 71.4 to 84.4
|
65.4 Percentage of Participants
Interval 54.0 to 75.7
|
43.4 Percentage of Participants
Interval 33.5 to 53.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 33F
|
19.1 Percentage of Participants
Interval 14.1 to 24.9
|
12.8 Percentage of Participants
Interval 7.4 to 20.3
|
72.5 Percentage of Participants
Interval 65.0 to 79.1
|
75.3 Percentage of Participants
Interval 64.5 to 84.2
|
27.3 Percentage of Participants
Interval 18.8 to 37.1
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 8
|
29.5 Percentage of Participants
Interval 23.6 to 36.0
|
0.9 Percentage of Participants
Interval 0.0 to 4.7
|
78.4 Percentage of Participants
Interval 71.4 to 84.4
|
76.5 Percentage of Participants
Interval 65.8 to 85.2
|
26.3 Percentage of Participants
Interval 17.9 to 36.1
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 9N
|
31.8 Percentage of Participants
Interval 25.7 to 38.4
|
7.7 Percentage of Participants
Interval 3.6 to 14.1
|
68.9 Percentage of Participants
Interval 61.2 to 75.8
|
72.8 Percentage of Participants
Interval 61.8 to 82.1
|
36.4 Percentage of Participants
Interval 26.9 to 46.6
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 10A
|
45.5 Percentage of Participants
Interval 38.7 to 52.3
|
0.9 Percentage of Participants
Interval 0.0 to 4.7
|
82.6 Percentage of Participants
Interval 76.0 to 88.1
|
80.2 Percentage of Participants
Interval 69.9 to 88.3
|
46.5 Percentage of Participants
Interval 36.4 to 56.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 11A
|
43.8 Percentage of Participants
Interval 37.2 to 50.7
|
0.0 Percentage of Participants
Interval 0.0 to 3.1
|
72.5 Percentage of Participants
Interval 65.0 to 79.1
|
63.0 Percentage of Participants
Interval 51.5 to 73.4
|
43.4 Percentage of Participants
Interval 33.5 to 53.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 12F
|
44.5 Percentage of Participants
Interval 37.9 to 51.4
|
2.6 Percentage of Participants
Interval 0.5 to 7.3
|
75.4 Percentage of Participants
Interval 68.2 to 81.8
|
60.5 Percentage of Participants
Interval 49.0 to 71.2
|
39.4 Percentage of Participants
Interval 29.7 to 49.7
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 15A
|
73.6 Percentage of Participants
Interval 67.3 to 79.3
|
0.9 Percentage of Participants
Interval 0.0 to 4.7
|
89.8 Percentage of Participants
Interval 84.2 to 94.0
|
28.4 Percentage of Participants
Interval 18.9 to 39.5
|
77.8 Percentage of Participants
Interval 68.3 to 85.5
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 15C
|
57.5 Percentage of Participants
Interval 50.7 to 64.2
|
3.4 Percentage of Participants
Interval 0.9 to 8.5
|
80.1 Percentage of Participants
Interval 73.2 to 85.9
|
64.2 Percentage of Participants
Interval 52.8 to 74.6
|
66.7 Percentage of Participants
Interval 56.5 to 75.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 16F
|
82.1 Percentage of Participants
Interval 76.4 to 87.0
|
2.6 Percentage of Participants
Interval 0.5 to 7.3
|
84.9 Percentage of Participants
Interval 78.6 to 90.0
|
13.6 Percentage of Participants
Interval 7.0 to 23.0
|
77.8 Percentage of Participants
Interval 68.3 to 85.5
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 17F
|
48.9 Percentage of Participants
Interval 42.1 to 55.7
|
1.7 Percentage of Participants
Interval 0.2 to 6.0
|
83.8 Percentage of Participants
Interval 77.4 to 89.1
|
74.1 Percentage of Participants
Interval 63.1 to 83.2
|
44.4 Percentage of Participants
Interval 34.5 to 54.8
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 23B
|
64.8 Percentage of Participants
Interval 58.1 to 71.2
|
26.5 Percentage of Participants
Interval 18.8 to 35.5
|
60.5 Percentage of Participants
Interval 52.6 to 67.9
|
21.0 Percentage of Participants
Interval 12.7 to 31.5
|
64.6 Percentage of Participants
Interval 54.4 to 74.0
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 24F
|
85.4 Percentage of Participants
Interval 80.0 to 89.8
|
0.0 Percentage of Participants
Interval 0.0 to 3.1
|
88.0 Percentage of Participants
Interval 82.1 to 92.5
|
0.0 Percentage of Participants
Interval 0.0 to 4.5
|
83.8 Percentage of Participants
Interval 75.1 to 90.5
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 35B
|
83.9 Percentage of Participants
Interval 78.4 to 88.6
|
0.0 Percentage of Participants
Interval 0.0 to 3.1
|
82.6 Percentage of Participants
Interval 76.0 to 88.1
|
0.0 Percentage of Participants
Interval 0.0 to 4.5
|
84.8 Percentage of Participants
Interval 76.2 to 91.3
|
|
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Serotype 31
|
79.7 Percentage of Participants
Interval 73.8 to 84.9
|
2.6 Percentage of Participants
Interval 0.5 to 7.3
|
84.4 Percentage of Participants
Interval 78.0 to 89.6
|
11.1 Percentage of Participants
Interval 5.2 to 20.0
|
80.8 Percentage of Participants
Interval 71.7 to 88.0
|
Adverse Events
Cohort 1: V116
Serious events: 2 serious events
Other events: 107 other events
Deaths: 0 deaths
Cohort 1: PCV15
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Cohort 2: V116
Serious events: 2 serious events
Other events: 85 other events
Deaths: 0 deaths
Cohort 2: PPSV23
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Cohort 3: V116
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: V116
n=230 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 participants at risk
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=174 participants at risk
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 participants at risk
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=105 participants at risk
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 2 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.43%
1/230 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.57%
1/174 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Gastrointestinal disorders
Aortoenteric fistula
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
1.2%
1/85 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.95%
1/105 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Infections and infestations
Injection site cellulitis
|
0.43%
1/230 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 2 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.95%
1/105 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
1.2%
1/85 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/117 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.57%
1/174 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
1.2%
1/85 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/230 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.85%
1/117 • Number of events 1 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/174 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/85 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
0.00%
0/105 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
Other adverse events
| Measure |
Cohort 1: V116
n=230 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment.
|
Cohort 1: PCV15
n=117 participants at risk
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
|
Cohort 2: V116
n=174 participants at risk
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
|
Cohort 2: PPSV23
n=85 participants at risk
Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
|
Cohort 3: V116
n=105 participants at risk
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
14.3%
33/230 • Number of events 33 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
17.1%
20/117 • Number of events 20 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
19.0%
33/174 • Number of events 34 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
14.1%
12/85 • Number of events 12 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
21.9%
23/105 • Number of events 23 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site erythema
|
8.3%
19/230 • Number of events 19 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
7.7%
9/117 • Number of events 9 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
8.0%
14/174 • Number of events 14 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.4%
8/85 • Number of events 8 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
7.6%
8/105 • Number of events 8 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site pain
|
35.7%
82/230 • Number of events 82 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
43.6%
51/117 • Number of events 51 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
41.4%
72/174 • Number of events 72 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
47.1%
40/85 • Number of events 40 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
43.8%
46/105 • Number of events 46 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site swelling
|
8.7%
20/230 • Number of events 20 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
8.5%
10/117 • Number of events 10 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
4.6%
8/174 • Number of events 8 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
16.5%
14/85 • Number of events 14 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
10.5%
11/105 • Number of events 11 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
17/230 • Number of events 17 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
4.3%
5/117 • Number of events 5 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.8%
17/174 • Number of events 17 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
10.6%
9/85 • Number of events 9 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
8.6%
9/105 • Number of events 9 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Nervous system disorders
Headache
|
7.4%
17/230 • Number of events 17 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.4%
11/117 • Number of events 11 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
10.3%
18/174 • Number of events 19 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
11.8%
10/85 • Number of events 10 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
8.6%
9/105 • Number of events 9 • Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The 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