Trial Outcomes & Findings for Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE) (NCT NCT03950622)
NCT ID: NCT03950622
Last Updated: 2021-04-26
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1205 participants
Primary outcome timeframe
Up to Day 5 postvaccination
Results posted on
2021-04-26
Participant Flow
Participant milestones
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
604
|
601
|
|
Overall Study
Vaccinated
|
602
|
600
|
|
Overall Study
COMPLETED
|
596
|
594
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
Baseline characteristics by cohort
| Measure |
V114
n=604 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=601 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
Total
n=1205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
65.7 Years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
65.9 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
691 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
245 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
469 Participants
n=5 Participants
|
471 Participants
n=7 Participants
|
940 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
410 Participants
n=5 Participants
|
407 Participants
n=7 Participants
|
817 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5 postvaccinationPopulation: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site erythema
|
9.0 Percentage of Participants
|
11.3 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site pain
|
54.0 Percentage of Participants
|
42.3 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event
Injection site swelling
|
12.5 Percentage of Participants
|
11.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 14 postvaccinationPopulation: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
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=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events
Muscle pain/myalgia
|
15.4 Percentage of Participants
|
12.0 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events
Joint pain/arthralgia
|
5.3 Percentage of Participants
|
5.5 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events
Tiredness/fatigue
|
17.4 Percentage of Participants
|
17.3 Percentage of Participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events
Headache
|
11.6 Percentage of Participants
|
13.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% CIs and 1-sided p-values 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) were determined using a multiplexed opsonophagocytic assay (MOPA). The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 1 (Shared)
|
256.3 Titers
|
322.6 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 3 (Shared)
|
216.2 Titers
|
135.1 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 4 (Shared)
|
1125.6 Titers
|
1661.6 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 5 (Shared)
|
447.3 Titers
|
563.5 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 6A (Shared)
|
5407.2 Titers
|
5424.5 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 6B (Shared)
|
4011.7 Titers
|
3258.2 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 7F (Shared)
|
4617.3 Titers
|
5880.6 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 9V (Shared)
|
1817.3 Titers
|
2232.9 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 14 (Shared)
|
1999.3 Titers
|
2656.7 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 18C (Shared)
|
2757.7 Titers
|
2583.7 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 19A (Shared)
|
3194.3 Titers
|
3979.8 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 19F (Shared)
|
1695.1 Titers
|
1917.8 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 23F (Shared)
|
2045.4 Titers
|
1740.4 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 22F (Unique to V114)
|
2375.2 Titers
|
74.6 Titers
|
|
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype 33F (Unique to V114)
|
7994.7 Titers
|
1124.9 Titers
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
Activity for the serotypes contained in Prevnar 13™ and V114 was determined using a multiplexed opsonophagocytic assay (MOPA). The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline (Day 1) to 30 days postvaccination (Day 30) for OPA responses for the 2 unique serotypes in V114. The observed response percentage (m/n) included: m=the number of participants with the indicated response divided by n=the number of participants contributing to the analysis. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes
Serotype 22F (Unique to V114)
|
71.4 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes
Serotype 33F (Unique to V114)
|
56.7 Percentage of Participants
|
6.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a 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 serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The measure type of "number" presented in the data table below for serotype-specific OPA titer is the geometric mean.
Outcome measures
| Measure |
V114
n=598 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=598 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
GMT of Serotype-specific OPA for Serotype 3 at Day 30
|
216.2 Titers
|
135.1 Titers
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
Activity for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The observed response percentage of participants (m/n) who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. n=Number of participants contributing to the analysis; m=Number of participants with the indicated response. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.
Outcome measures
| Measure |
V114
n=580 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=576 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses
|
70.2 Percentage of Participants
|
58.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a 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. The measure type of "number" presented in the data table below for serotype-specific IgG concentration is the geometric mean.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 1 (Shared)
|
5.30 µg/mL
|
7.34 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 3 (Shared)
|
0.96 µg/mL
|
0.64 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 4 (Shared)
|
1.88 µg/mL
|
2.62 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 5 (Shared)
|
4.57 µg/mL
|
5.56 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 6A (Shared)
|
7.21 µg/mL
|
7.01 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 6B (Shared)
|
8.60 µg/mL
|
6.19 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 7F (Shared)
|
6.18 µg/mL
|
8.09 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 9V (Shared)
|
4.77 µg/mL
|
5.52 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 14 (Shared)
|
9.39 µg/mL
|
12.30 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 18C (Shared)
|
8.99 µg/mL
|
10.00 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 19A (Shared)
|
14.60 µg/mL
|
17.38 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 19F (Shared)
|
8.77 µg/mL
|
9.70 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 23F (Shared)
|
6.67 µg/mL
|
6.13 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 22F (Unique to V114)
|
3.44 µg/mL
|
0.32 µg/mL
|
|
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype 33F (Unique to V114)
|
11.05 µg/mL
|
1.23 µg/mL
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
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 defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 1 (Shared)
|
14.3 Ratio
Interval 12.5 to 16.4
|
18.7 Ratio
Interval 16.2 to 21.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 3 (Shared)
|
7.7 Ratio
Interval 7.0 to 8.6
|
5.2 Ratio
Interval 4.7 to 5.7
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 4 (Shared)
|
17.8 Ratio
Interval 15.7 to 20.3
|
24.4 Ratio
Interval 21.3 to 27.8
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 5 (Shared)
|
12.3 Ratio
Interval 10.7 to 14.2
|
15.3 Ratio
Interval 13.2 to 17.6
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 6A (Shared)
|
13.0 Ratio
Interval 11.4 to 14.9
|
13.3 Ratio
Interval 11.6 to 15.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 6B (Shared)
|
26.3 Ratio
Interval 22.4 to 30.8
|
21.6 Ratio
Interval 18.5 to 25.2
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 7F (Shared)
|
12.0 Ratio
Interval 10.3 to 13.9
|
14.1 Ratio
Interval 12.1 to 16.5
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 9V (Shared)
|
5.3 Ratio
Interval 4.8 to 6.0
|
6.3 Ratio
Interval 5.6 to 7.1
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 14 (Shared)
|
6.2 Ratio
Interval 5.4 to 7.2
|
8.7 Ratio
Interval 7.5 to 10.0
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 18C (Shared)
|
11.3 Ratio
Interval 10.0 to 12.9
|
10.4 Ratio
Interval 9.1 to 11.8
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 19A (Shared)
|
10.9 Ratio
Interval 9.5 to 12.5
|
13.1 Ratio
Interval 11.4 to 15.1
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 19F (Shared)
|
6.6 Ratio
Interval 5.9 to 7.5
|
7.4 Ratio
Interval 6.6 to 8.3
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 23F (Shared)
|
16.2 Ratio
Interval 14.0 to 18.9
|
13.5 Ratio
Interval 11.5 to 15.9
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 22F (Unique to V114)
|
28.3 Ratio
Interval 22.8 to 35.1
|
1.2 Ratio
Interval 1.0 to 1.4
|
|
Geometric Mean Fold Rise in Serotype-specific OPA
Serotype 33F (Unique to V114)
|
7.4 Ratio
Interval 6.4 to 8.6
|
1.0 Ratio
Interval 1.0 to 1.2
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
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. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 1 (Shared)
|
10.6 Ratio
Interval 9.4 to 12.0
|
14.7 Ratio
Interval 13.1 to 16.6
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 3 (Shared)
|
6.8 Ratio
Interval 6.2 to 7.6
|
4.7 Ratio
Interval 4.2 to 5.1
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 4 (Shared)
|
8.0 Ratio
Interval 7.2 to 9.0
|
11.2 Ratio
Interval 10.0 to 12.5
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 5 (Shared)
|
4.7 Ratio
Interval 4.2 to 5.2
|
5.8 Ratio
Interval 5.2 to 6.5
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 6A (Shared)
|
19.9 Ratio
Interval 17.6 to 22.6
|
19.7 Ratio
Interval 17.4 to 22.3
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 6B (Shared)
|
19.1 Ratio
Interval 16.8 to 21.7
|
13.8 Ratio
Interval 12.3 to 15.6
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 7F (Shared)
|
12.3 Ratio
Interval 10.9 to 13.9
|
15.8 Ratio
Interval 13.9 to 18.0
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 9V (Shared)
|
9.9 Ratio
Interval 8.9 to 11.1
|
11.1 Ratio
Interval 9.9 to 12.4
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 14 (Shared)
|
5.1 Ratio
Interval 4.5 to 5.7
|
7.2 Ratio
Interval 6.3 to 8.2
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 18C (Shared)
|
12.8 Ratio
Interval 11.3 to 14.5
|
14.3 Ratio
Interval 12.6 to 16.2
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 19A (Shared)
|
8.7 Ratio
Interval 7.8 to 9.8
|
10.6 Ratio
Interval 9.5 to 11.9
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 19F (Shared)
|
10.9 Ratio
Interval 9.7 to 12.3
|
12.5 Ratio
Interval 11.1 to 14.0
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 23F (Shared)
|
13.5 Ratio
Interval 11.9 to 15.3
|
12.2 Ratio
Interval 10.8 to 13.7
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 22F (Unique to V114)
|
11.7 Ratio
Interval 10.3 to 13.3
|
1.1 Ratio
Interval 1.1 to 1.1
|
|
Geometric Mean Fold Rise in Serotype-specific IgG
Serotype 33F (Unique to V114)
|
9.1 Ratio
Interval 8.0 to 10.2
|
1.0 Ratio
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
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. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Outcome measures
| Measure |
V114
n=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 1 (Shared)
|
75.1 Percentage of Participants
Interval 71.4 to 78.6
|
77.7 Percentage of Participants
Interval 74.0 to 81.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 3 (Shared)
|
70.2 Percentage of Participants
Interval 66.3 to 73.9
|
58.7 Percentage of Participants
Interval 54.5 to 62.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 4 (Shared)
|
79.5 Percentage of Participants
Interval 76.0 to 82.7
|
84.8 Percentage of Participants
Interval 81.6 to 87.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 5 (Shared)
|
71.6 Percentage of Participants
Interval 67.8 to 75.2
|
75.3 Percentage of Participants
Interval 71.6 to 78.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 6A (Shared)
|
76.5 Percentage of Participants
Interval 72.7 to 80.0
|
74.9 Percentage of Participants
Interval 71.1 to 78.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 6B (Shared)
|
81.2 Percentage of Participants
Interval 77.7 to 84.3
|
79.2 Percentage of Participants
Interval 75.6 to 82.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 7F (Shared)
|
66.4 Percentage of Participants
Interval 62.4 to 70.3
|
72.4 Percentage of Participants
Interval 68.5 to 76.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 9V (Shared)
|
54.0 Percentage of Participants
Interval 49.8 to 58.1
|
60.0 Percentage of Participants
Interval 55.9 to 64.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 14 (Shared)
|
52.2 Percentage of Participants
Interval 48.0 to 56.3
|
60.8 Percentage of Participants
Interval 56.6 to 64.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 18C (Shared)
|
71.3 Percentage of Participants
Interval 67.4 to 74.9
|
69.1 Percentage of Participants
Interval 65.1 to 72.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 19A (Shared)
|
70.6 Percentage of Participants
Interval 66.7 to 74.2
|
71.1 Percentage of Participants
Interval 67.2 to 74.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 19F (Shared)
|
62.0 Percentage of Participants
Interval 57.9 to 66.0
|
65.1 Percentage of Participants
Interval 61.1 to 69.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 23F (Shared)
|
75.0 Percentage of Participants
Interval 71.1 to 78.5
|
71.4 Percentage of Participants
Interval 67.4 to 75.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 22F (Unique to V114)
|
71.4 Percentage of Participants
Interval 67.3 to 75.2
|
14.3 Percentage of Participants
Interval 11.3 to 17.6
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Serotype 33F (Unique to V114)
|
56.7 Percentage of Participants
Interval 52.6 to 60.8
|
6.3 Percentage of Participants
Interval 4.4 to 8.6
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 30Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
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=602 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
Prevnar 13™
n=600 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 1 (Shared)
|
73.1 Percentage of Participants
Interval 69.4 to 76.7
|
78.4 Percentage of Participants
Interval 74.9 to 81.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 3 (Shared)
|
61.6 Percentage of Participants
Interval 57.5 to 65.5
|
51.4 Percentage of Participants
Interval 47.2 to 55.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 4 (Shared)
|
65.0 Percentage of Participants
Interval 61.0 to 68.9
|
76.0 Percentage of Participants
Interval 72.3 to 79.4
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 5 (Shared)
|
45.1 Percentage of Participants
Interval 41.0 to 49.2
|
53.4 Percentage of Participants
Interval 49.3 to 57.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 6A (Shared)
|
83.5 Percentage of Participants
Interval 80.3 to 86.4
|
83.4 Percentage of Participants
Interval 80.1 to 86.3
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 6B (Shared)
|
82.8 Percentage of Participants
Interval 79.5 to 85.8
|
77.5 Percentage of Participants
Interval 73.9 to 80.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 7F (Shared)
|
73.5 Percentage of Participants
Interval 69.7 to 77.0
|
78.6 Percentage of Participants
Interval 75.0 to 81.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 9V (Shared)
|
69.6 Percentage of Participants
Interval 65.7 to 73.3
|
75.5 Percentage of Participants
Interval 71.8 to 79.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 14 (Shared)
|
49.4 Percentage of Participants
Interval 45.3 to 53.5
|
59.5 Percentage of Participants
Interval 55.4 to 63.5
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 18C (Shared)
|
73.1 Percentage of Participants
Interval 69.4 to 76.7
|
76.3 Percentage of Participants
Interval 72.7 to 79.7
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 19A (Shared)
|
67.2 Percentage of Participants
Interval 63.2 to 71.0
|
71.2 Percentage of Participants
Interval 67.4 to 74.9
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 19F (Shared)
|
69.5 Percentage of Participants
Interval 65.6 to 73.2
|
75.5 Percentage of Participants
Interval 71.8 to 79.0
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 23F (Shared)
|
74.9 Percentage of Participants
Interval 71.2 to 78.4
|
74.3 Percentage of Participants
Interval 70.6 to 77.8
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 22F (Unique to V114)
|
71.4 Percentage of Participants
Interval 67.6 to 75.0
|
1.7 Percentage of Participants
Interval 0.8 to 3.1
|
|
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Serotype 33F (Unique to V114)
|
66.5 Percentage of Participants
Interval 62.5 to 70.3
|
1.7 Percentage of Participants
Interval 0.8 to 3.1
|
Adverse Events
V114
Serious events: 9 serious events
Other events: 395 other events
Deaths: 1 deaths
PCV13
Serious events: 13 serious events
Other events: 336 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
V114
n=602 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
PCV13
n=600 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
General disorders
Death
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Infections and infestations
Viral infection
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.17%
1/602 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.00%
0/600 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/602 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
0.17%
1/600 • Number of events 1 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
Other adverse events
| Measure |
V114
n=602 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
|
PCV13
n=600 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
General disorders
Fatigue
|
17.4%
105/602 • Number of events 144 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
17.3%
104/600 • Number of events 140 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
General disorders
Injection site erythema
|
10.0%
60/602 • Number of events 62 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
12.2%
73/600 • Number of events 77 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
General disorders
Injection site pain
|
54.3%
327/602 • Number of events 367 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
42.8%
257/600 • Number of events 294 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
General disorders
Injection site swelling
|
12.6%
76/602 • Number of events 79 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
12.2%
73/600 • Number of events 78 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
32/602 • Number of events 38 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
5.5%
33/600 • Number of events 39 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
93/602 • Number of events 111 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
12.0%
72/600 • Number of events 85 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
|
Nervous system disorders
Headache
|
11.6%
70/602 • Number of events 93 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
13.0%
78/600 • Number of events 105 • Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~Month 6 (Up to 194 days after vaccination).
The analysis population for adverse events and serious adverse events: all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received. The analysis population for the all cause mortality: all randomized participants.
|
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