Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH) (NCT NCT03480763)
NCT ID: NCT03480763
Last Updated: 2021-11-02
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 treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
652 participants
Primary outcome timeframe
Up to 5 days after Vaccination 1
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
V114
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Overall Study
STARTED
|
327
|
325
|
|
Overall Study
Vaccination 1 - (V114 or Prevnar 13™, Day 1)
|
326
|
325
|
|
Overall Study
Vaccination 2 - (PNEUMOVAX™23, Month 12)
|
298
|
302
|
|
Overall Study
COMPLETED
|
303
|
306
|
|
Overall Study
NOT COMPLETED
|
24
|
19
|
Reasons for withdrawal
| Measure |
V114
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
non-study pneumococcal vaccine
|
1
|
0
|
|
Overall Study
oncological treatment
|
0
|
2
|
|
Overall Study
pain with vaccination
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
Baseline characteristics by cohort
| Measure |
V114
n=327 Participants
Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
283 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
206 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after Vaccination 1Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Outcome measures
| Measure |
V114
n=327 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=324 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site redness/erythema
|
9.8 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site tenderness/pain
|
55.0 Percentage of Participants
|
41.4 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Injection site swelling
|
16.2 Percentage of Participants
|
11.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after Vaccination 2Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Outcome measures
| Measure |
V114
n=298 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=302 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site redness/erythema
|
17.4 Percentage of Participants
|
16.9 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site tenderness/pain
|
62.1 Percentage of Participants
|
58.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Injection site swelling
|
28.2 Percentage of Participants
|
26.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after Vaccination 1Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Outcome measures
| Measure |
V114
n=327 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=324 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Joint pain/arthralgia
|
6.4 Percentage of Participants
|
5.2 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Tiredness/fatigue
|
23.5 Percentage of Participants
|
13.9 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Headache
|
14.1 Percentage of Participants
|
12.7 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Muscle pain/myalgia
|
17.7 Percentage of Participants
|
11.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after Vaccination 2Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Outcome measures
| Measure |
V114
n=298 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=302 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Joint pain/arthralgia
|
8.4 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Tiredness/fatigue
|
25.8 Percentage of Participants
|
21.9 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Headache
|
12.1 Percentage of Participants
|
12.6 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Muscle pain/myalgia
|
21.5 Percentage of Participants
|
16.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after Vaccination 1Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
Outcome measures
| Measure |
V114
n=327 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=324 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 12 to Month 13 (Up to 44 days after Vaccination 2)Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
Outcome measures
| Measure |
V114
n=298 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=302 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Month 13 (30 days after Vaccination 2)Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 1 (Shared)
|
392.2 Titers
|
283.2 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 3 (Shared)
|
282.6 Titers
|
262.8 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 4 (Shared)
|
1671.9 Titers
|
1580.4 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 5 (Shared)
|
705.5 Titers
|
583.9 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 6A (Shared)
|
3261.5 Titers
|
2806.8 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 6B (Shared)
|
3223.9 Titers
|
2872.0 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 7F (Shared)
|
5125.6 Titers
|
4848.0 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 9V (Shared)
|
2059.5 Titers
|
1872.0 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 14 (Shared)
|
3370.9 Titers
|
2660.5 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 18C (Shared)
|
2379.6 Titers
|
2103.9 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 19A (Shared)
|
3657.1 Titers
|
3170.8 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 19F (Shared)
|
2229.7 Titers
|
2156.2 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 23F (Shared)
|
1894.2 Titers
|
1485.1 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 22F (Unique to V114)
|
3124.4 Titers
|
1921.6 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype 33F (Unique to V114)
|
7881.6 Titers
|
8269.9 Titers
|
SECONDARY outcome
Timeframe: Month 13 (30 days after Vaccination 2)Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 1 (Shared)
|
5.21 µg/mL
|
5.68 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 3 (Shared)
|
1.05 µg/mL
|
1.05 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 4 (Shared)
|
1.99 µg/mL
|
2.29 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 5 (Shared)
|
5.77 µg/mL
|
5.82 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 6A (Shared)
|
4.97 µg/mL
|
4.28 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 6B (Shared)
|
6.71 µg/mL
|
5.77 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 7F (Shared)
|
5.99 µg/mL
|
6.06 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 9V (Shared)
|
4.96 µg/mL
|
4.75 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 14 (Shared)
|
14.82 µg/mL
|
12.72 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 18C (Shared)
|
7.31 µg/mL
|
6.29 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 19A (Shared)
|
13.10 µg/mL
|
11.88 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 19F (Shared)
|
9.38 µg/mL
|
8.62 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 23F (Shared)
|
4.83 µg/mL
|
4.24 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 22F (Unique to V114)
|
4.85 µg/mL
|
3.39 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype 33F (Unique to V114)
|
10.60 µg/mL
|
13.30 µg/mL
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMT of Serotype-specific OPA at Day 30
Serotype 14 (Shared)
|
2677.3 Titers
|
2458.1 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 1 (Shared)
|
361.6 Titers
|
296.2 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 3 (Shared)
|
245.4 Titers
|
129.4 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 4 (Shared)
|
1280.4 Titers
|
1685.9 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 5 (Shared)
|
699.0 Titers
|
655.9 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 6A (Shared)
|
7352.8 Titers
|
6184.2 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 6B (Shared)
|
5958.1 Titers
|
3631.2 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 7F (Shared)
|
4966.9 Titers
|
5207.6 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 9V (Shared)
|
2329.9 Titers
|
2293.0 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 18C (Shared)
|
4298.2 Titers
|
2896.3 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 19A (Shared)
|
4856.1 Titers
|
3783.0 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 19F (Shared)
|
2418.8 Titers
|
2203.5 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 23F (Shared)
|
2648.7 Titers
|
1726.9 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 22F (Unique to V114)
|
3471.1 Titers
|
99.6 Titers
|
|
GMT of Serotype-specific OPA at Day 30
Serotype 33F (Unique to V114)
|
11392.4 Titers
|
1244.7 Titers
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMC of Serotype-specific IgG at Day 30
Serotype 1 (Shared)
|
6.97 µg/mL
|
7.86 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 3 (Shared)
|
1.02 µg/mL
|
0.59 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 4 (Shared)
|
2.36 µg/mL
|
2.98 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 5 (Shared)
|
5.43 µg/mL
|
5.21 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 6A (Shared)
|
11.48 µg/mL
|
8.22 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 6B (Shared)
|
13.69 µg/mL
|
8.35 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 7F (Shared)
|
7.14 µg/mL
|
7.82 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 9V (Shared)
|
6.10 µg/mL
|
5.39 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 14 (Shared)
|
12.68 µg/mL
|
11.59 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 18C (Shared)
|
16.67 µg/mL
|
10.66 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 19A (Shared)
|
18.59 µg/mL
|
16.48 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 19F (Shared)
|
12.00 µg/mL
|
10.53 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 23F (Shared)
|
9.76 µg/mL
|
6.07 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 22F (Unique to V114)
|
5.07 µg/mL
|
0.31 µg/mL
|
|
GMC of Serotype-specific IgG at Day 30
Serotype 33F (Unique to V114)
|
14.31 µg/mL
|
1.12 µg/mL
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 1 (Shared)
|
22.3 Ratio
Interval 18.5 to 26.9
|
16.7 Ratio
Interval 13.8 to 20.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 3 (Shared)
|
8.0 Ratio
Interval 6.9 to 9.2
|
4.4 Ratio
Interval 3.8 to 5.1
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 4 (Shared)
|
18.3 Ratio
Interval 15.0 to 22.4
|
23.3 Ratio
Interval 19.3 to 28.3
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 5 (Shared)
|
17.2 Ratio
Interval 14.2 to 20.9
|
16.2 Ratio
Interval 13.3 to 19.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6A (Shared)
|
17.4 Ratio
Interval 14.2 to 21.2
|
13.9 Ratio
Interval 11.5 to 16.8
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 6B (Shared)
|
28.5 Ratio
Interval 23.1 to 35.2
|
18.4 Ratio
Interval 14.9 to 22.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 7F (Shared)
|
10.7 Ratio
Interval 8.7 to 13.0
|
10.5 Ratio
Interval 8.5 to 13.1
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 9V (Shared)
|
6.1 Ratio
Interval 5.2 to 7.1
|
5.6 Ratio
Interval 4.7 to 6.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 14 (Shared)
|
6.6 Ratio
Interval 5.4 to 8.0
|
6.0 Ratio
Interval 4.9 to 7.4
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 18C (Shared)
|
18.1 Ratio
Interval 15.1 to 21.7
|
12.2 Ratio
Interval 10.2 to 14.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19A (Shared)
|
13.4 Ratio
Interval 11.1 to 16.3
|
10.0 Ratio
Interval 8.4 to 12.0
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 19F (Shared)
|
7.8 Ratio
Interval 6.7 to 9.2
|
6.4 Ratio
Interval 5.5 to 7.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 23F (Shared)
|
18.8 Ratio
Interval 15.2 to 23.1
|
12.2 Ratio
Interval 9.8 to 15.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 22F (Unique to V114)
|
32.5 Ratio
Interval 24.2 to 43.6
|
1.1 Ratio
Interval 0.8 to 1.4
|
|
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Serotype 33F (Unique to V114)
|
8.3 Ratio
Interval 6.7 to 10.1
|
0.9 Ratio
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 1 (Shared)
|
13.0 Ratio
Interval 11.0 to 15.3
|
14.4 Ratio
Interval 12.3 to 16.8
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 3 (Shared)
|
6.7 Ratio
Interval 5.8 to 7.8
|
3.9 Ratio
Interval 3.4 to 4.3
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 4 (Shared)
|
10.1 Ratio
Interval 8.6 to 11.9
|
12.4 Ratio
Interval 10.6 to 14.5
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 5 (Shared)
|
5.6 Ratio
Interval 4.8 to 6.5
|
5.2 Ratio
Interval 4.4 to 6.2
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 6A (Shared)
|
30.2 Ratio
Interval 25.3 to 36.1
|
20.8 Ratio
Interval 17.5 to 24.6
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 6B (Shared)
|
28.2 Ratio
Interval 23.4 to 34.1
|
17.1 Ratio
Interval 14.4 to 20.4
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 7F (Shared)
|
13.6 Ratio
Interval 11.5 to 16.1
|
14.3 Ratio
Interval 12.1 to 17.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 9V (Shared)
|
11.7 Ratio
Interval 9.9 to 13.9
|
10.3 Ratio
Interval 8.8 to 12.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 14 (Shared)
|
6.6 Ratio
Interval 5.4 to 7.9
|
6.3 Ratio
Interval 5.3 to 7.5
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 18C (Shared)
|
22.4 Ratio
Interval 18.7 to 26.7
|
13.7 Ratio
Interval 11.6 to 16.2
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 19A (Shared)
|
11.3 Ratio
Interval 9.5 to 13.5
|
9.5 Ratio
Interval 8.1 to 11.1
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 19F (Shared)
|
14.2 Ratio
Interval 12.0 to 16.9
|
11.9 Ratio
Interval 10.2 to 14.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 23F (Shared)
|
17.7 Ratio
Interval 14.7 to 21.3
|
11.0 Ratio
Interval 9.3 to 13.1
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 22F (Unique to V114)
|
14.9 Ratio
Interval 12.4 to 18.0
|
0.9 Ratio
Interval 0.9 to 1.0
|
|
GMFR in Serotype-specific IgG Day 1 to Day 30
Serotype 33F (Unique to V114)
|
11.1 Ratio
Interval 9.3 to 13.1
|
0.8 Ratio
Interval 0.8 to 0.9
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 3 (Shared)
|
72.1 Percentage of Participants
Interval 66.7 to 77.1
|
51.1 Percentage of Participants
Interval 45.4 to 56.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 4 (Shared)
|
79.3 Percentage of Participants
Interval 74.4 to 83.7
|
84.6 Percentage of Participants
Interval 80.1 to 88.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 5 (Shared)
|
76.8 Percentage of Participants
Interval 71.7 to 81.4
|
79.0 Percentage of Participants
Interval 74.1 to 83.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 6A (Shared)
|
79.2 Percentage of Participants
Interval 74.0 to 83.8
|
78.1 Percentage of Participants
Interval 72.8 to 82.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 6B (Shared)
|
83.4 Percentage of Participants
Interval 78.8 to 87.5
|
76.1 Percentage of Participants
Interval 71.0 to 80.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 7F (Shared)
|
67.2 Percentage of Participants
Interval 61.6 to 72.5
|
65.9 Percentage of Participants
Interval 60.2 to 71.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 9V (Shared)
|
61.2 Percentage of Participants
Interval 55.4 to 66.8
|
56.8 Percentage of Participants
Interval 51.1 to 62.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 14 (Shared)
|
53.0 Percentage of Participants
Interval 47.2 to 58.7
|
53.2 Percentage of Participants
Interval 47.5 to 58.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 18C (Shared)
|
83.4 Percentage of Participants
Interval 78.7 to 87.4
|
74.2 Percentage of Participants
Interval 68.9 to 79.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 19A (Shared)
|
70.4 Percentage of Participants
Interval 64.9 to 75.5
|
69.6 Percentage of Participants
Interval 64.1 to 74.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 19F (Shared)
|
63.4 Percentage of Participants
Interval 57.7 to 68.9
|
56.2 Percentage of Participants
Interval 50.4 to 61.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 23F (Shared)
|
79.2 Percentage of Participants
Interval 74.0 to 83.8
|
70.8 Percentage of Participants
Interval 65.2 to 76.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 22F (Unique to V114)
|
72.8 Percentage of Participants
Interval 66.8 to 78.2
|
16.5 Percentage of Participants
Interval 12.1 to 21.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 33F (Unique to V114)
|
61.3 Percentage of Participants
Interval 55.6 to 66.8
|
3.0 Percentage of Participants
Interval 1.4 to 5.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Serotype 1 (Shared)
|
83.4 Percentage of Participants
Interval 78.7 to 87.4
|
76.1 Percentage of Participants
Interval 71.0 to 80.7
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 6A (Shared)
|
88.4 Percentage of Participants
Interval 84.3 to 91.8
|
84.3 Percentage of Participants
Interval 79.8 to 88.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 1 (Shared)
|
74.9 Percentage of Participants
Interval 69.7 to 79.6
|
80.8 Percentage of Participants
Interval 76.1 to 85.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 3 (Shared)
|
62.4 Percentage of Participants
Interval 56.7 to 67.8
|
42.8 Percentage of Participants
Interval 37.3 to 48.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 4 (Shared)
|
71.4 Percentage of Participants
Interval 66.0 to 76.3
|
74.2 Percentage of Participants
Interval 69.0 to 78.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 5 (Shared)
|
52.4 Percentage of Participants
Interval 46.7 to 58.1
|
49.4 Percentage of Participants
Interval 43.7 to 55.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 6B (Shared)
|
85.5 Percentage of Participants
Interval 81.1 to 89.2
|
77.4 Percentage of Participants
Interval 72.4 to 81.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 7F (Shared)
|
76.8 Percentage of Participants
Interval 71.8 to 81.4
|
75.5 Percentage of Participants
Interval 70.4 to 80.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 9V (Shared)
|
73.0 Percentage of Participants
Interval 67.7 to 77.8
|
70.4 Percentage of Participants
Interval 65.1 to 75.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 14 (Shared)
|
54.0 Percentage of Participants
Interval 48.3 to 59.7
|
56.0 Percentage of Participants
Interval 50.3 to 61.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 18C (Shared)
|
83.9 Percentage of Participants
Interval 79.4 to 87.8
|
75.5 Percentage of Participants
Interval 70.4 to 80.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 19A (Shared)
|
71.4 Percentage of Participants
Interval 66.0 to 76.3
|
69.2 Percentage of Participants
Interval 63.8 to 74.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 19F (Shared)
|
77.5 Percentage of Participants
Interval 72.4 to 82.0
|
76.3 Percentage of Participants
Interval 71.3 to 80.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 23F (Shared)
|
79.7 Percentage of Participants
Interval 74.8 to 84.1
|
70.1 Percentage of Participants
Interval 64.8 to 75.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 22F (Unique to V114)
|
76.8 Percentage of Participants
Interval 71.8 to 81.4
|
0.9 Percentage of Participants
Interval 0.2 to 2.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Serotype 33F (Unique to V114)
|
71.1 Percentage of Participants
Interval 65.7 to 76.0
|
0.6 Percentage of Participants
Interval 0.1 to 2.3
|
SECONDARY outcome
Timeframe: Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMT of Serotype-specific OPA at Month 12
Serotype 18C (Shared)
|
1520.4 Titers
|
1191.8 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 23F (Shared)
|
984.7 Titers
|
720.3 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 22F (Unique to V114)
|
1267.4 Titers
|
99.1 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 33F (Unique to V114)
|
4099.0 Titers
|
1266.6 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 1 (Shared)
|
138.2 Titers
|
116.2 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 3 (Shared)
|
88.3 Titers
|
56.3 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 4 (Shared)
|
477.2 Titers
|
666.5 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 5 (Shared)
|
213.4 Titers
|
209.6 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 6A (Shared)
|
2421.7 Titers
|
2111.3 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 6B (Shared)
|
2079.7 Titers
|
1453.7 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 7F (Shared)
|
2161.8 Titers
|
2291.1 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 9V (Shared)
|
1006.8 Titers
|
1030.5 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 14 (Shared)
|
1543.8 Titers
|
1395.1 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 19A (Shared)
|
1724.3 Titers
|
1575.3 Titers
|
|
GMT of Serotype-specific OPA at Month 12
Serotype 19F (Shared)
|
948.4 Titers
|
876.0 Titers
|
SECONDARY outcome
Timeframe: Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMC of Serotype-specific IgG at Month 12
Serotype 7F (Shared)
|
2.95 µg/mL
|
3.45 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 9V (Shared)
|
2.85 µg/mL
|
2.75 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 14 (Shared)
|
7.91 µg/mL
|
7.50 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 18C (Shared)
|
5.99 µg/mL
|
4.32 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 6B (Shared)
|
5.13 µg/mL
|
3.46 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 19A (Shared)
|
8.19 µg/mL
|
7.22 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 1 (Shared)
|
2.73 µg/mL
|
3.52 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 19F (Shared)
|
4.67 µg/mL
|
4.14 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 23F (Shared)
|
3.57 µg/mL
|
2.66 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 22F (Unique to V114)
|
2.07 µg/mL
|
0.33 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 33F (Unique to V114)
|
6.24 µg/mL
|
1.24 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 3 (Shared)
|
0.39 µg/mL
|
0.28 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 4 (Shared)
|
1.00 µg/mL
|
1.31 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 5 (Shared)
|
2.59 µg/mL
|
2.91 µg/mL
|
|
GMC of Serotype-specific IgG at Month 12
Serotype 6A (Shared)
|
4.27 µg/mL
|
3.13 µg/mL
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 3 (Shared)
|
3.0 Ratio
Interval 2.6 to 3.5
|
2.1 Ratio
Interval 1.9 to 2.4
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 4 (Shared)
|
7.0 Ratio
Interval 5.8 to 8.3
|
9.4 Ratio
Interval 7.7 to 11.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 6B (Shared)
|
10.4 Ratio
Interval 8.4 to 12.7
|
7.3 Ratio
Interval 6.1 to 8.8
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 7F (Shared)
|
4.6 Ratio
Interval 3.8 to 5.5
|
4.9 Ratio
Interval 4.1 to 6.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 19F (Shared)
|
3.0 Ratio
Interval 2.6 to 3.5
|
2.8 Ratio
Interval 2.5 to 3.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 1 (Shared)
|
9.2 Ratio
Interval 7.7 to 11.1
|
7.3 Ratio
Interval 6.1 to 8.7
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 5 (Shared)
|
5.5 Ratio
Interval 4.6 to 6.7
|
5.7 Ratio
Interval 4.7 to 6.9
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 6A (Shared)
|
5.7 Ratio
Interval 4.9 to 6.8
|
4.9 Ratio
Interval 4.2 to 5.7
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 9V (Shared)
|
2.7 Ratio
Interval 2.3 to 3.1
|
2.7 Ratio
Interval 2.3 to 3.1
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 14 (Shared)
|
3.9 Ratio
Interval 3.3 to 4.7
|
3.5 Ratio
Interval 2.9 to 4.2
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 18C (Shared)
|
6.5 Ratio
Interval 5.6 to 7.6
|
5.2 Ratio
Interval 4.5 to 6.1
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 19A (Shared)
|
4.9 Ratio
Interval 4.1 to 5.9
|
4.3 Ratio
Interval 3.6 to 5.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 23F (Shared)
|
7.1 Ratio
Interval 5.8 to 8.7
|
5.1 Ratio
Interval 4.2 to 6.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 22F (Unique to V114)
|
12.3 Ratio
Interval 9.3 to 16.3
|
1.3 Ratio
Interval 1.0 to 1.6
|
|
GMFR in Serotype-specific OPA Day 1 to Month 12
Serotype 33F (Unique to V114)
|
3.0 Ratio
Interval 2.5 to 3.6
|
0.9 Ratio
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 14 (Shared)
|
3.9 Ratio
Interval 3.4 to 4.6
|
4.1 Ratio
Interval 3.5 to 4.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 1 (Shared)
|
5.2 Ratio
Interval 4.5 to 6.0
|
6.6 Ratio
Interval 5.7 to 7.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 3 (Shared)
|
2.6 Ratio
Interval 2.3 to 2.9
|
1.8 Ratio
Interval 1.7 to 2.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 4 (Shared)
|
4.3 Ratio
Interval 3.8 to 4.9
|
5.5 Ratio
Interval 4.8 to 6.3
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 5 (Shared)
|
2.7 Ratio
Interval 2.4 to 3.0
|
3.0 Ratio
Interval 2.6 to 3.4
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 6A (Shared)
|
11.1 Ratio
Interval 9.5 to 13.0
|
8.1 Ratio
Interval 6.9 to 9.3
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 6B (Shared)
|
10.3 Ratio
Interval 8.7 to 12.2
|
7.2 Ratio
Interval 6.2 to 8.4
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 7F (Shared)
|
5.5 Ratio
Interval 4.8 to 6.2
|
6.4 Ratio
Interval 5.5 to 7.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 9V (Shared)
|
5.6 Ratio
Interval 4.9 to 6.4
|
5.4 Ratio
Interval 4.7 to 6.1
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 18C (Shared)
|
8.0 Ratio
Interval 6.9 to 9.3
|
5.6 Ratio
Interval 4.9 to 6.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 19A (Shared)
|
4.9 Ratio
Interval 4.3 to 5.6
|
4.3 Ratio
Interval 3.8 to 4.9
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 19F (Shared)
|
5.2 Ratio
Interval 4.6 to 6.0
|
4.9 Ratio
Interval 4.3 to 5.6
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 23F (Shared)
|
6.6 Ratio
Interval 5.7 to 7.6
|
4.9 Ratio
Interval 4.3 to 5.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 22F (Unique to V114)
|
6.0 Ratio
Interval 5.1 to 7.0
|
1.0 Ratio
Interval 0.9 to 1.1
|
|
GMFR in Serotype-specific IgG Day 1 to Month 12
Serotype 33F (Unique to V114)
|
4.7 Ratio
Interval 4.1 to 5.4
|
0.9 Ratio
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 1 (Shared)
|
69.4 Percentage of Participants
Interval 63.6 to 74.7
|
61.4 Percentage of Participants
Interval 55.4 to 67.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 3 (Shared)
|
39.4 Percentage of Participants
Interval 33.6 to 45.5
|
25.7 Percentage of Participants
Interval 20.7 to 31.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 4 (Shared)
|
63.0 Percentage of Participants
Interval 57.1 to 68.8
|
67.1 Percentage of Participants
Interval 61.3 to 72.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 5 (Shared)
|
58.4 Percentage of Participants
Interval 52.4 to 64.2
|
57.5 Percentage of Participants
Interval 51.5 to 63.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 6A (Shared)
|
61.2 Percentage of Participants
Interval 54.9 to 67.2
|
54.3 Percentage of Participants
Interval 48.0 to 60.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 6B (Shared)
|
68.8 Percentage of Participants
Interval 62.9 to 74.2
|
60.4 Percentage of Participants
Interval 54.4 to 66.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 7F (Shared)
|
50.4 Percentage of Participants
Interval 44.2 to 56.5
|
48.9 Percentage of Participants
Interval 42.7 to 55.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 9V (Shared)
|
34.6 Percentage of Participants
Interval 28.9 to 40.5
|
32.0 Percentage of Participants
Interval 26.5 to 37.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 14 (Shared)
|
41.6 Percentage of Participants
Interval 35.7 to 47.7
|
42.2 Percentage of Participants
Interval 36.3 to 48.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 18C (Shared)
|
63.3 Percentage of Participants
Interval 57.3 to 69.0
|
54.4 Percentage of Participants
Interval 48.3 to 60.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 19A (Shared)
|
53.2 Percentage of Participants
Interval 47.0 to 59.2
|
47.5 Percentage of Participants
Interval 41.4 to 53.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 19F (Shared)
|
41.2 Percentage of Participants
Interval 35.2 to 47.4
|
35.3 Percentage of Participants
Interval 29.6 to 41.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 23F (Shared)
|
62.4 Percentage of Participants
Interval 56.1 to 68.3
|
53.5 Percentage of Participants
Interval 47.2 to 59.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 22F (Unique to V114)
|
64.0 Percentage of Participants
Interval 57.4 to 70.3
|
14.1 Percentage of Participants
Interval 9.7 to 19.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Serotype 33F (Unique to V114)
|
34.5 Percentage of Participants
Interval 29.0 to 40.4
|
4.8 Percentage of Participants
Interval 2.6 to 8.1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 12Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 3 (Shared)
|
27.0 Percentage of Participants
Interval 21.9 to 32.5
|
12.4 Percentage of Participants
Interval 8.8 to 16.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 4 (Shared)
|
47.2 Percentage of Participants
Interval 41.2 to 53.2
|
57.7 Percentage of Participants
Interval 51.6 to 63.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 5 (Shared)
|
30.9 Percentage of Participants
Interval 25.5 to 36.6
|
34.4 Percentage of Participants
Interval 28.9 to 40.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 6A (Shared)
|
75.5 Percentage of Participants
Interval 70.1 to 80.4
|
66.7 Percentage of Participants
Interval 60.8 to 72.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 7F (Shared)
|
59.9 Percentage of Participants
Interval 54.0 to 65.7
|
64.9 Percentage of Participants
Interval 59.0 to 70.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 9V (Shared)
|
60.6 Percentage of Participants
Interval 54.7 to 66.4
|
55.3 Percentage of Participants
Interval 49.3 to 61.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 14 (Shared)
|
42.6 Percentage of Participants
Interval 36.7 to 48.6
|
46.8 Percentage of Participants
Interval 40.9 to 52.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 18C (Shared)
|
70.2 Percentage of Participants
Interval 64.5 to 75.5
|
58.5 Percentage of Participants
Interval 52.5 to 64.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 19A (Shared)
|
53.9 Percentage of Participants
Interval 47.9 to 59.8
|
50.0 Percentage of Participants
Interval 44.0 to 56.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 1 (Shared)
|
56.0 Percentage of Participants
Interval 50.0 to 61.9
|
65.6 Percentage of Participants
Interval 59.7 to 71.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 6B (Shared)
|
73.0 Percentage of Participants
Interval 67.5 to 78.1
|
62.1 Percentage of Participants
Interval 56.1 to 67.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 19F (Shared)
|
56.9 Percentage of Participants
Interval 50.9 to 62.8
|
52.3 Percentage of Participants
Interval 46.3 to 58.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 23F (Shared)
|
59.6 Percentage of Participants
Interval 53.6 to 65.4
|
51.4 Percentage of Participants
Interval 45.4 to 57.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 22F (Unique to V114)
|
58.9 Percentage of Participants
Interval 52.9 to 64.7
|
1.8 Percentage of Participants
Interval 0.6 to 4.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Serotype 33F (Unique to V114)
|
52.5 Percentage of Participants
Interval 46.5 to 58.4
|
1.1 Percentage of Participants
Interval 0.2 to 3.1
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 1 (Shared)
|
24.7 Ratio
Interval 20.7 to 29.4
|
15.5 Ratio
Interval 12.9 to 18.5
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 3 (Shared)
|
9.1 Ratio
Interval 7.9 to 10.5
|
8.7 Ratio
Interval 7.5 to 10.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 4 (Shared)
|
23.8 Ratio
Interval 19.5 to 29.2
|
21.5 Ratio
Interval 17.5 to 26.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 5 (Shared)
|
17.2 Ratio
Interval 14.1 to 21.1
|
14.5 Ratio
Interval 12.0 to 17.5
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 6A (Shared)
|
7.7 Ratio
Interval 6.5 to 9.2
|
6.3 Ratio
Interval 5.4 to 7.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 6B (Shared)
|
16.2 Ratio
Interval 13.3 to 19.8
|
14.3 Ratio
Interval 11.7 to 17.4
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 7F (Shared)
|
11.0 Ratio
Interval 9.0 to 13.4
|
10.2 Ratio
Interval 8.2 to 12.5
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 9V (Shared)
|
5.2 Ratio
Interval 4.5 to 6.1
|
4.6 Ratio
Interval 3.9 to 5.3
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 14 (Shared)
|
8.2 Ratio
Interval 6.8 to 9.8
|
6.7 Ratio
Interval 5.6 to 8.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 18C (Shared)
|
10.1 Ratio
Interval 8.6 to 11.7
|
9.0 Ratio
Interval 7.7 to 10.4
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 19A (Shared)
|
10.4 Ratio
Interval 8.5 to 12.6
|
8.5 Ratio
Interval 7.2 to 10.2
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 19F (Shared)
|
7.0 Ratio
Interval 6.0 to 8.1
|
6.3 Ratio
Interval 5.5 to 7.2
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 23F (Shared)
|
12.6 Ratio
Interval 10.3 to 15.5
|
9.7 Ratio
Interval 7.8 to 12.0
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 22F (Unique to V114)
|
30.2 Ratio
Interval 22.7 to 40.1
|
16.2 Ratio
Interval 11.8 to 22.2
|
|
GMFR in Serotype-specific OPA Day 1 to Month 13
Serotype 33F (Unique to V114)
|
5.8 Ratio
Interval 4.8 to 7.0
|
5.5 Ratio
Interval 4.5 to 6.7
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 1 (Shared)
|
9.9 Ratio
Interval 8.7 to 11.4
|
10.5 Ratio
Interval 9.1 to 12.2
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 3 (Shared)
|
6.9 Ratio
Interval 6.0 to 7.8
|
6.7 Ratio
Interval 6.0 to 7.6
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 4 (Shared)
|
8.6 Ratio
Interval 7.6 to 9.8
|
9.5 Ratio
Interval 8.3 to 11.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 5 (Shared)
|
5.9 Ratio
Interval 5.2 to 6.8
|
5.9 Ratio
Interval 5.2 to 6.8
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 6A (Shared)
|
13.1 Ratio
Interval 11.2 to 15.3
|
10.8 Ratio
Interval 9.3 to 12.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 6B (Shared)
|
13.7 Ratio
Interval 11.7 to 16.1
|
11.9 Ratio
Interval 10.2 to 13.9
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 7F (Shared)
|
11.1 Ratio
Interval 9.8 to 12.7
|
11.2 Ratio
Interval 9.7 to 12.9
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 9V (Shared)
|
9.8 Ratio
Interval 8.5 to 11.3
|
9.2 Ratio
Interval 8.0 to 10.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 14 (Shared)
|
7.4 Ratio
Interval 6.3 to 8.7
|
6.9 Ratio
Interval 5.9 to 8.1
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 18C (Shared)
|
9.8 Ratio
Interval 8.5 to 11.3
|
8.2 Ratio
Interval 7.1 to 9.4
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 19A (Shared)
|
7.9 Ratio
Interval 6.9 to 9.0
|
7.0 Ratio
Interval 6.1 to 8.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 19F (Shared)
|
10.7 Ratio
Interval 9.3 to 12.4
|
10.0 Ratio
Interval 8.6 to 11.5
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 23F (Shared)
|
9.1 Ratio
Interval 7.9 to 10.5
|
7.6 Ratio
Interval 6.6 to 8.7
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 22F (Unique to V114)
|
14.2 Ratio
Interval 12.0 to 16.7
|
10.0 Ratio
Interval 8.4 to 12.0
|
|
GMFR in Serotype-specific IgG Day 1 to Month 13
Serotype 33F (Unique to V114)
|
8.1 Ratio
Interval 7.1 to 9.2
|
10.1 Ratio
Interval 8.6 to 11.8
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 1 (Shared)
|
87.9 Percentage of Participants
Interval 83.4 to 91.5
|
78.8 Percentage of Participants
Interval 73.4 to 83.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 3 (Shared)
|
78.7 Percentage of Participants
Interval 73.3 to 83.5
|
76.0 Percentage of Participants
Interval 70.4 to 81.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 4 (Shared)
|
83.7 Percentage of Participants
Interval 78.7 to 87.9
|
84.3 Percentage of Participants
Interval 79.4 to 88.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 5 (Shared)
|
79.9 Percentage of Participants
Interval 74.6 to 84.4
|
80.9 Percentage of Participants
Interval 75.7 to 85.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 6A (Shared)
|
68.3 Percentage of Participants
Interval 62.1 to 74.1
|
64.5 Percentage of Participants
Interval 58.1 to 70.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 6B (Shared)
|
78.0 Percentage of Participants
Interval 72.5 to 82.9
|
77.1 Percentage of Participants
Interval 71.5 to 82.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 7F (Shared)
|
72.1 Percentage of Participants
Interval 66.3 to 77.5
|
64.6 Percentage of Participants
Interval 58.3 to 70.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 9V (Shared)
|
55.8 Percentage of Participants
Interval 49.6 to 61.9
|
50.8 Percentage of Participants
Interval 44.6 to 56.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 14 (Shared)
|
63.8 Percentage of Participants
Interval 57.7 to 69.6
|
58.7 Percentage of Participants
Interval 52.5 to 64.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 18C (Shared)
|
75.7 Percentage of Participants
Interval 70.1 to 80.7
|
73.7 Percentage of Participants
Interval 68.0 to 78.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 19A (Shared)
|
70.2 Percentage of Participants
Interval 64.3 to 75.7
|
66.3 Percentage of Participants
Interval 60.3 to 71.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 19F (Shared)
|
68.4 Percentage of Participants
Interval 62.4 to 74.0
|
62.1 Percentage of Participants
Interval 56.0 to 68.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 23F (Shared)
|
74.4 Percentage of Participants
Interval 68.5 to 79.7
|
66.3 Percentage of Participants
Interval 60.0 to 72.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 22F (Unique to V114)
|
79.5 Percentage of Participants
Interval 73.6 to 84.6
|
62.6 Percentage of Participants
Interval 56.0 to 68.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Serotype 33F (Unique to V114)
|
55.8 Percentage of Participants
Interval 49.6 to 61.8
|
51.6 Percentage of Participants
Interval 45.3 to 57.8
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 1 (Shared)
|
79.5 Percentage of Participants
Interval 74.2 to 84.1
|
78.5 Percentage of Participants
Interval 73.1 to 83.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 3 (Shared)
|
72.5 Percentage of Participants
Interval 66.8 to 77.7
|
68.6 Percentage of Participants
Interval 62.8 to 74.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 4 (Shared)
|
76.6 Percentage of Participants
Interval 71.1 to 81.5
|
75.5 Percentage of Participants
Interval 69.9 to 80.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 5 (Shared)
|
59.7 Percentage of Participants
Interval 53.6 to 65.6
|
59.9 Percentage of Participants
Interval 53.8 to 65.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 6A (Shared)
|
81.0 Percentage of Participants
Interval 75.8 to 85.4
|
77.0 Percentage of Participants
Interval 71.6 to 81.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 6B (Shared)
|
81.0 Percentage of Participants
Interval 75.8 to 85.4
|
77.0 Percentage of Participants
Interval 71.6 to 81.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 7F (Shared)
|
81.7 Percentage of Participants
Interval 76.6 to 86.1
|
81.4 Percentage of Participants
Interval 76.3 to 85.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 9V (Shared)
|
76.2 Percentage of Participants
Interval 70.7 to 81.1
|
73.4 Percentage of Participants
Interval 67.7 to 78.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 14 (Shared)
|
68.5 Percentage of Participants
Interval 62.6 to 74.0
|
63.9 Percentage of Participants
Interval 57.9 to 69.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 18C (Shared)
|
78.0 Percentage of Participants
Interval 72.6 to 82.8
|
70.8 Percentage of Participants
Interval 65.0 to 76.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 19A (Shared)
|
70.0 Percentage of Participants
Interval 64.1 to 75.3
|
66.4 Percentage of Participants
Interval 60.5 to 72.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 19F (Shared)
|
77.3 Percentage of Participants
Interval 71.9 to 82.1
|
74.0 Percentage of Participants
Interval 68.4 to 79.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 23F (Shared)
|
72.2 Percentage of Participants
Interval 66.4 to 77.4
|
69.7 Percentage of Participants
Interval 63.9 to 75.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 22F (Unique to V114)
|
80.6 Percentage of Participants
Interval 75.4 to 85.1
|
71.9 Percentage of Participants
Interval 66.2 to 77.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Serotype 33F (Unique to V114)
|
75.5 Percentage of Participants
Interval 69.9 to 80.4
|
76.6 Percentage of Participants
Interval 71.2 to 81.5
|
SECONDARY outcome
Timeframe: Month 12 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 1 (Shared)
|
2.7 Ratio
Interval 2.4 to 3.0
|
2.3 Ratio
Interval 2.0 to 2.6
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 3 (Shared)
|
3.0 Ratio
Interval 2.7 to 3.4
|
4.1 Ratio
Interval 3.6 to 4.6
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 4 (Shared)
|
3.3 Ratio
Interval 2.9 to 3.9
|
2.3 Ratio
Interval 2.0 to 2.6
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 5 (Shared)
|
3.1 Ratio
Interval 2.7 to 3.5
|
2.6 Ratio
Interval 2.3 to 2.9
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 6A (Shared)
|
1.3 Ratio
Interval 1.2 to 1.5
|
1.3 Ratio
Interval 1.2 to 1.5
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 6B (Shared)
|
1.5 Ratio
Interval 1.4 to 1.7
|
1.9 Ratio
Interval 1.8 to 2.2
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 7F (Shared)
|
2.3 Ratio
Interval 2.1 to 2.6
|
2.1 Ratio
Interval 1.9 to 2.3
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 9V (Shared)
|
2.0 Ratio
Interval 1.8 to 2.2
|
1.7 Ratio
Interval 1.6 to 2.0
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 14 (Shared)
|
2.1 Ratio
Interval 1.9 to 2.4
|
1.9 Ratio
Interval 1.7 to 2.1
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 18C (Shared)
|
1.5 Ratio
Interval 1.4 to 1.7
|
1.7 Ratio
Interval 1.5 to 1.9
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 19A (Shared)
|
2.1 Ratio
Interval 1.9 to 2.4
|
2.0 Ratio
Interval 1.8 to 2.3
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 19F (Shared)
|
2.3 Ratio
Interval 2.0 to 2.6
|
2.3 Ratio
Interval 2.1 to 2.6
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 23F (Shared)
|
1.9 Ratio
Interval 1.6 to 2.1
|
1.9 Ratio
Interval 1.7 to 2.2
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 22F (Unique to V114)
|
2.5 Ratio
Interval 2.1 to 2.9
|
14.2 Ratio
Interval 10.6 to 19.0
|
|
GMFR in Serotype-specific OPA Month 12 to Month 13
Serotype 33F (Unique to V114)
|
2.0 Ratio
Interval 1.8 to 2.2
|
6.2 Ratio
Interval 5.2 to 7.5
|
SECONDARY outcome
Timeframe: Month 12 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 33F (Unique to V114)
|
1.7 Ratio
Interval 1.6 to 1.9
|
10.7 Ratio
Interval 9.1 to 12.5
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 1 (Shared)
|
1.9 Ratio
Interval 1.8 to 2.1
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 3 (Shared)
|
2.6 Ratio
Interval 2.4 to 2.9
|
3.7 Ratio
Interval 3.3 to 4.1
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 4 (Shared)
|
2.0 Ratio
Interval 1.8 to 2.2
|
1.7 Ratio
Interval 1.6 to 1.9
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 5 (Shared)
|
2.3 Ratio
Interval 2.1 to 2.5
|
2.0 Ratio
Interval 1.8 to 2.1
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 6A (Shared)
|
1.2 Ratio
Interval 1.1 to 1.2
|
1.3 Ratio
Interval 1.3 to 1.4
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 6B (Shared)
|
1.3 Ratio
Interval 1.2 to 1.4
|
1.6 Ratio
Interval 1.5 to 1.8
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 7F (Shared)
|
2.1 Ratio
Interval 1.9 to 2.2
|
1.8 Ratio
Interval 1.6 to 1.9
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 9V (Shared)
|
1.8 Ratio
Interval 1.6 to 1.9
|
1.7 Ratio
Interval 1.6 to 1.9
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 14 (Shared)
|
1.9 Ratio
Interval 1.7 to 2.1
|
1.7 Ratio
Interval 1.6 to 1.8
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 18C (Shared)
|
1.2 Ratio
Interval 1.2 to 1.3
|
1.5 Ratio
Interval 1.4 to 1.6
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 19A (Shared)
|
1.6 Ratio
Interval 1.5 to 1.7
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 19F (Shared)
|
2.0 Ratio
Interval 1.9 to 2.2
|
2.1 Ratio
Interval 1.9 to 2.3
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 23F (Shared)
|
1.4 Ratio
Interval 1.3 to 1.5
|
1.6 Ratio
Interval 1.5 to 1.7
|
|
GMFR in Serotype-specific IgG Month 12 to Month 13
Serotype 22F (Unique to V114)
|
2.4 Ratio
Interval 2.2 to 2.6
|
10.0 Ratio
Interval 8.4 to 11.9
|
SECONDARY outcome
Timeframe: Month 12 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 1 (Shared)
|
29.7 Percentage of Participants
Interval 24.3 to 35.5
|
25.6 Percentage of Participants
Interval 20.5 to 31.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 3 (Shared)
|
39.0 Percentage of Participants
Interval 33.1 to 45.1
|
49.6 Percentage of Participants
Interval 43.5 to 55.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 4 (Shared)
|
36.3 Percentage of Participants
Interval 30.6 to 42.3
|
22.3 Percentage of Participants
Interval 17.5 to 27.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 5 (Shared)
|
34.9 Percentage of Participants
Interval 29.3 to 40.9
|
29.2 Percentage of Participants
Interval 23.9 to 35.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 6A (Shared)
|
9.1 Percentage of Participants
Interval 5.9 to 13.2
|
10.4 Percentage of Participants
Interval 7.1 to 14.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 6B (Shared)
|
8.8 Percentage of Participants
Interval 5.7 to 12.8
|
16.1 Percentage of Participants
Interval 11.9 to 21.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 7F (Shared)
|
24.7 Percentage of Participants
Interval 19.7 to 30.3
|
21.2 Percentage of Participants
Interval 16.5 to 26.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 9V (Shared)
|
20.1 Percentage of Participants
Interval 15.5 to 25.3
|
16.5 Percentage of Participants
Interval 12.3 to 21.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 14 (Shared)
|
21.3 Percentage of Participants
Interval 16.6 to 26.7
|
12.9 Percentage of Participants
Interval 9.1 to 17.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 18C (Shared)
|
10.7 Percentage of Participants
Interval 7.3 to 15.0
|
15.7 Percentage of Participants
Interval 11.6 to 20.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 19A (Shared)
|
20.4 Percentage of Participants
Interval 15.7 to 25.7
|
17.9 Percentage of Participants
Interval 13.6 to 23.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 19F (Shared)
|
25.3 Percentage of Participants
Interval 20.2 to 30.9
|
27.4 Percentage of Participants
Interval 22.2 to 33.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 23F (Shared)
|
19.0 Percentage of Participants
Interval 14.5 to 24.2
|
17.8 Percentage of Participants
Interval 13.4 to 22.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 22F (Unique to V114)
|
26.8 Percentage of Participants
Interval 21.6 to 32.6
|
62.0 Percentage of Participants
Interval 55.6 to 68.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Serotype 33F (Unique to V114)
|
22.1 Percentage of Participants
Interval 17.3 to 27.6
|
54.4 Percentage of Participants
Interval 48.1 to 60.5
|
SECONDARY outcome
Timeframe: Month 12 (Baseline) and Month 13Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=326 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=325 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 14 (Shared)
|
14.2 Percentage of Participants
Interval 10.3 to 18.9
|
9.5 Percentage of Participants
Interval 6.3 to 13.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 1 (Shared)
|
15.0 Percentage of Participants
Interval 11.0 to 19.7
|
8.8 Percentage of Participants
Interval 5.7 to 12.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 3 (Shared)
|
31.4 Percentage of Participants
Interval 25.9 to 37.2
|
43.8 Percentage of Participants
Interval 37.8 to 49.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 4 (Shared)
|
14.2 Percentage of Participants
Interval 10.3 to 18.9
|
8.8 Percentage of Participants
Interval 5.7 to 12.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 5 (Shared)
|
20.1 Percentage of Participants
Interval 15.5 to 25.3
|
15.0 Percentage of Participants
Interval 11.0 to 19.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 6A (Shared)
|
1.1 Percentage of Participants
Interval 0.2 to 3.2
|
4.4 Percentage of Participants
Interval 2.3 to 7.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 6B (Shared)
|
4.7 Percentage of Participants
Interval 2.6 to 8.0
|
11.3 Percentage of Participants
Interval 7.8 to 15.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 7F (Shared)
|
17.2 Percentage of Participants
Interval 12.9 to 22.1
|
10.2 Percentage of Participants
Interval 6.9 to 14.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 9V (Shared)
|
10.6 Percentage of Participants
Interval 7.2 to 14.8
|
9.1 Percentage of Participants
Interval 6.0 to 13.2
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 18C (Shared)
|
0.4 Percentage of Participants
Interval 0.0 to 2.0
|
6.9 Percentage of Participants
Interval 4.2 to 10.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 19A (Shared)
|
8.0 Percentage of Participants
Interval 5.1 to 11.9
|
7.7 Percentage of Participants
Interval 4.8 to 11.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 19F (Shared)
|
13.9 Percentage of Participants
Interval 10.0 to 18.6
|
17.9 Percentage of Participants
Interval 13.5 to 22.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 22F (Shared)
|
3.6 Percentage of Participants
Interval 1.8 to 6.6
|
10.2 Percentage of Participants
Interval 6.9 to 14.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 23F (Unique to V114)
|
21.5 Percentage of Participants
Interval 16.8 to 26.9
|
71.2 Percentage of Participants
Interval 65.4 to 76.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Serotype 33F (Unique to V114)
|
10.6 Percentage of Participants
Interval 7.2 to 14.8
|
77.0 Percentage of Participants
Interval 71.6 to 81.9
|
Adverse Events
V114
Serious events: 17 serious events
Other events: 221 other events
Deaths: 0 deaths
Prevnar 13™
Serious events: 19 serious events
Other events: 181 other events
Deaths: 0 deaths
V114 (Post-PNEUMOVAX™23)
Serious events: 1 serious events
Other events: 217 other events
Deaths: 0 deaths
Prevnar 13™ (Post-PNEUMOVAX™23)
Serious events: 2 serious events
Other events: 210 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=327 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=324 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
V114 (Post-PNEUMOVAX™23)
n=298 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=302 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.33%
1/302 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.33%
1/302 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Syncope
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.33%
1/302 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.34%
1/298 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Cardiac disorders
Cardiac failure
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.31%
1/327 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Asthenia
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Hangover
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Pyrexia
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Infections and infestations
Cellulitis
|
0.61%
2/327 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Infections and infestations
Osteomyelitis
|
0.61%
2/327 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Infections and infestations
Pneumonia
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
2/327 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.62%
2/324 • Number of events 2 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Presyncope
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Psychiatric disorders
Delirium tremens
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Renal and urinary disorders
Calculus urinary
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/327 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/324 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/327 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.31%
1/324 • Number of events 1 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/298 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
0.00%
0/302 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
Other adverse events
| Measure |
V114
n=327 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™
n=324 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
V114 (Post-PNEUMOVAX™23)
n=298 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
Prevnar 13™ (Post-PNEUMOVAX™23)
n=302 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
23.5%
77/327 • Number of events 89 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
13.9%
45/324 • Number of events 53 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
25.8%
77/298 • Number of events 103 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
21.9%
66/302 • Number of events 77 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Injection site erythema
|
11.9%
39/327 • Number of events 41 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
8.0%
26/324 • Number of events 28 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
17.8%
53/298 • Number of events 57 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
16.9%
51/302 • Number of events 53 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Injection site pain
|
55.4%
181/327 • Number of events 204 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
42.3%
137/324 • Number of events 155 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
62.4%
186/298 • Number of events 210 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
58.6%
177/302 • Number of events 210 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
General disorders
Injection site swelling
|
16.5%
54/327 • Number of events 55 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
12.3%
40/324 • Number of events 43 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
28.2%
84/298 • Number of events 85 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
26.2%
79/302 • Number of events 82 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
21/327 • Number of events 26 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
5.2%
17/324 • Number of events 19 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
8.4%
25/298 • Number of events 34 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
8.3%
25/302 • Number of events 26 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.7%
58/327 • Number of events 62 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
11.1%
36/324 • Number of events 39 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
21.5%
64/298 • Number of events 71 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
16.6%
50/302 • Number of events 55 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
|
Nervous system disorders
Headache
|
14.1%
46/327 • Number of events 58 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
12.7%
41/324 • Number of events 52 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
12.1%
36/298 • Number of events 43 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
12.6%
38/302 • Number of events 46 • Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER