Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) (NCT NCT02573181)
NCT ID: NCT02573181
Last Updated: 2019-08-14
Results Overview
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
Up to Day 44 after vaccination
Results posted on
2019-08-14
Participant Flow
Participants were recruited at 17 study centers in the United States.
Participant milestones
| Measure |
V114
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
126
|
|
Overall Study
Vaccinated
|
127
|
126
|
|
Overall Study
COMPLETED
|
127
|
126
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
Baseline characteristics by cohort
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.7 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
72.7 Years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
72.7 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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 44 after vaccinationPopulation: All participants who received study vaccination are included.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event (AE)
|
68.5 Percentage of Participants
|
64.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 5 after vaccinationPopulation: All participants who received study vaccination are included.
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Erythema/Redness
|
7.9 Percentage of Participants
|
7.1 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Swelling
|
14.2 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Tenderness/Pain
|
55.1 Percentage of Participants
|
44.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 14 after vaccinationPopulation: All participants who received study vaccination are included.
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Fatigue
|
18.1 Percentage of Participants
|
19.0 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Arthralgia
|
5.5 Percentage of Participants
|
8.7 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Myalgia
|
15.7 Percentage of Participants
|
11.1 Percentage of Participants
|
|
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Headache
|
13.4 Percentage of Participants
|
15.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations are included.
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23F Day 30
|
4.01 µg/mL
Interval 2.94 to 5.46
|
3.35 µg/mL
Interval 2.41 to 4.65
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 1 Day 1
|
1.11 µg/mL
Interval 0.85 to 1.45
|
1.27 µg/mL
Interval 0.98 to 1.64
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 1 Day 30
|
3.31 µg/mL
Interval 2.6 to 4.23
|
3.42 µg/mL
Interval 2.61 to 4.47
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 3 Day 1
|
0.19 µg/mL
Interval 0.15 to 0.23
|
0.19 µg/mL
Interval 0.15 to 0.24
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 3 Day 30
|
0.72 µg/mL
Interval 0.57 to 0.91
|
0.46 µg/mL
Interval 0.36 to 0.58
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 4 Day 1
|
0.32 µg/mL
Interval 0.25 to 0.41
|
0.33 µg/mL
Interval 0.26 to 0.43
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 4 Day 30
|
1.13 µg/mL
Interval 0.88 to 1.45
|
1.15 µg/mL
Interval 0.88 to 1.51
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 5 Day 1
|
1.31 µg/mL
Interval 1.01 to 1.7
|
1.48 µg/mL
Interval 1.14 to 1.91
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 5 Day 30
|
2.69 µg/mL
Interval 2.05 to 3.53
|
3.67 µg/mL
Interval 2.75 to 4.9
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6A Day 1
|
0.48 µg/mL
Interval 0.36 to 0.64
|
0.47 µg/mL
Interval 0.36 to 0.6
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6A Day 30
|
3.85 µg/mL
Interval 2.77 to 5.36
|
4.34 µg/mL
Interval 3.17 to 5.94
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6B Day 1
|
0.64 µg/mL
Interval 0.48 to 0.87
|
0.67 µg/mL
Interval 0.52 to 0.87
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6B Day 30
|
3.74 µg/mL
Interval 2.74 to 5.13
|
3.70 µg/mL
Interval 2.72 to 5.04
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 7F Day 1
|
1.25 µg/mL
Interval 0.94 to 1.67
|
1.01 µg/mL
Interval 0.78 to 1.3
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 7F Day 30
|
3.85 µg/mL
Interval 2.96 to 5.0
|
3.24 µg/mL
Interval 2.54 to 4.12
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 9V Day 1
|
1.26 µg/mL
Interval 0.99 to 1.61
|
1.04 µg/mL
Interval 0.84 to 1.29
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 9V Day 30
|
3.79 µg/mL
Interval 2.95 to 4.86
|
2.72 µg/mL
Interval 2.17 to 3.41
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 14 Day 1
|
2.84 µg/mL
Interval 2.12 to 3.81
|
4.10 µg/mL
Interval 3.13 to 5.35
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 14 Day 30
|
5.46 µg/mL
Interval 4.16 to 7.17
|
6.45 µg/mL
Interval 5.0 to 8.32
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 18C Day 1
|
1.69 µg/mL
Interval 1.28 to 2.22
|
1.76 µg/mL
Interval 1.38 to 2.24
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 18C Day 30
|
6.85 µg/mL
Interval 5.22 to 8.98
|
5.30 µg/mL
Interval 4.15 to 6.77
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19A Day 1
|
3.28 µg/mL
Interval 2.54 to 4.24
|
3.29 µg/mL
Interval 2.59 to 4.18
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19A Day 30
|
9.3 µg/mL
Interval 7.32 to 11.8
|
9.41 µg/mL
Interval 7.76 to 11.41
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19F Day 1
|
1.46 µg/mL
Interval 1.1 to 1.94
|
1.45 µg/mL
Interval 1.12 to 1.88
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19F Day 30
|
5.06 µg/mL
Interval 3.82 to 6.69
|
4.35 µg/mL
Interval 3.35 to 5.66
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 22F Day 1
|
0.74 µg/mL
Interval 0.57 to 0.96
|
0.68 µg/mL
Interval 0.52 to 0.89
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 22F Day 30
|
2.57 µg/mL
Interval 1.97 to 3.35
|
0.60 µg/mL
Interval 0.46 to 0.79
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23F Day 1
|
0.71 µg/mL
Interval 0.54 to 0.93
|
0.73 µg/mL
Interval 0.55 to 0.96
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 33F Day 1
|
2.98 µg/mL
Interval 2.24 to 3.96
|
3.30 µg/mL
Interval 2.58 to 4.23
|
|
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 33F Day 30
|
6.57 µg/mL
Interval 5.14 to 8.41
|
3.11 µg/mL
Interval 2.4 to 4.04
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.
The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 18C
|
4.06 GMFR
Interval 3.19 to 5.15
|
2.93 GMFR
Interval 2.37 to 3.64
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19A
|
2.85 GMFR
Interval 2.32 to 3.5
|
2.81 GMFR
Interval 2.35 to 3.37
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19F
|
3.37 GMFR
Interval 2.68 to 4.24
|
2.86 GMFR
Interval 2.36 to 3.46
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 22F
|
3.27 GMFR
Interval 2.62 to 4.08
|
0.90 GMFR
Interval 0.87 to 0.94
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23F
|
5.26 GMFR
Interval 4.14 to 6.68
|
4.24 GMFR
Interval 3.34 to 5.38
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 33F
|
2.22 GMFR
Interval 1.81 to 2.74
|
0.91 GMFR
Interval 0.88 to 0.95
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 1
|
2.98 GMFR
Interval 2.39 to 3.73
|
2.70 GMFR
Interval 2.17 to 3.35
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 3
|
3.14 GMFR
Interval 2.54 to 3.88
|
2.03 GMFR
Interval 1.78 to 2.33
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 4
|
3.37 GMFR
Interval 2.66 to 4.26
|
3.28 GMFR
Interval 2.73 to 3.95
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 5
|
2.14 GMFR
Interval 1.82 to 2.5
|
2.39 GMFR
Interval 1.97 to 2.91
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6A
|
7.09 GMFR
Interval 5.71 to 8.79
|
8.24 GMFR
Interval 6.39 to 10.62
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6B
|
5.20 GMFR
Interval 4.19 to 6.46
|
4.92 GMFR
Interval 3.9 to 6.22
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 7F
|
2.97 GMFR
Interval 2.44 to 3.63
|
3.03 GMFR
Interval 2.46 to 3.74
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 9V
|
2.98 GMFR
Interval 2.42 to 3.67
|
2.57 GMFR
Interval 2.18 to 3.05
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 14
|
1.90 GMFR
Interval 1.56 to 2.32
|
1.48 GMFR
Interval 1.28 to 1.72
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 7F
|
31.1 Percentage of Participants
Interval 22.93 to 40.23
|
33.3 Percentage of Participants
Interval 24.89 to 42.64
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 9V
|
35.3 Percentage of Participants
Interval 26.76 to 44.58
|
23.9 Percentage of Participants
Interval 16.53 to 32.7
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 14
|
18.5 Percentage of Participants
Interval 11.96 to 26.64
|
9.4 Percentage of Participants
Interval 4.79 to 16.2
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 1
|
32.8 Percentage of Participants
Interval 24.45 to 41.98
|
26.5 Percentage of Participants
Interval 18.77 to 35.45
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 3
|
36.1 Percentage of Participants
Interval 27.53 to 45.45
|
17.1 Percentage of Participants
Interval 10.77 to 25.16
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 4
|
36.1 Percentage of Participants
Interval 27.53 to 45.45
|
35.9 Percentage of Participants
Interval 27.24 to 45.29
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 18C
|
46.2 Percentage of Participants
Interval 37.04 to 55.59
|
30.8 Percentage of Participants
Interval 22.57 to 39.97
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19A
|
31.1 Percentage of Participants
Interval 22.93 to 40.23
|
35.0 Percentage of Participants
Interval 26.45 to 44.41
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 19F
|
35.3 Percentage of Participants
Interval 26.76 to 44.58
|
33.3 Percentage of Participants
Interval 24.89 to 42.64
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 22F
|
31.9 Percentage of Participants
Interval 23.69 to 41.1
|
0.0 Percentage of Participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 23F
|
52.9 Percentage of Participants
Interval 43.58 to 62.15
|
45.3 Percentage of Participants
Interval 36.08 to 54.77
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 33F
|
24.4 Percentage of Participants
Interval 16.97 to 33.09
|
0.0 Percentage of Participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 5
|
19.3 Percentage of Participants
Interval 12.66 to 27.58
|
23.9 Percentage of Participants
Interval 16.53 to 32.7
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6A
|
64.7 Percentage of Participants
Interval 55.42 to 73.24
|
65.0 Percentage of Participants
Interval 55.59 to 73.55
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
Serotype 6B
|
54.6 Percentage of Participants
Interval 45.24 to 63.77
|
46.2 Percentage of Participants
Interval 36.9 to 55.61
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations are included.
The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6B Day 1
|
175.69 Titers
Interval 113.53 to 271.9
|
132.41 Titers
Interval 84.39 to 207.76
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6B Day 30
|
2389.20 Titers
Interval 1747.68 to 3266.19
|
2423.27 Titers
Interval 1731.26 to 3391.9
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 7F Day 1
|
228.75 Titers
Interval 150.65 to 347.35
|
205.76 Titers
Interval 132.0 to 320.73
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 7F Day 30
|
1232.86 Titers
Interval 905.89 to 1677.85
|
1664.85 Titers
Interval 1328.78 to 2085.92
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 9V Day 1
|
320.81 Titers
Interval 221.32 to 465.02
|
222.07 Titers
Interval 146.84 to 335.85
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 9V Day 30
|
1962.51 Titers
Interval 1450.32 to 2655.58
|
1387.45 Titers
Interval 1008.48 to 1908.82
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 14 Day 1
|
451.24 Titers
Interval 312.11 to 652.39
|
475.62 Titers
Interval 349.01 to 648.15
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 14 Day 30
|
1228.80 Titers
Interval 964.72 to 1565.18
|
899.66 Titers
Interval 683.7 to 1183.84
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 18C Day 1
|
180.26 Titers
Interval 121.6 to 267.21
|
205.56 Titers
Interval 143.28 to 294.93
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 18C Day 30
|
1550.65 Titers
Interval 1172.29 to 2051.13
|
1009.16 Titers
Interval 728.59 to 1397.79
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 1 Day 1
|
20.30 Titers
Interval 14.87 to 27.7
|
24.24 Titers
Interval 17.24 to 33.12
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 1 Day 30
|
109.25 Titers
Interval 79.47 to 150.19
|
91.53 Titers
Interval 65.77 to 127.37
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 3 Day 1
|
23.37 Titers
Interval 17.56 to 31.09
|
26.71 Titers
Interval 19.84 to 35.96
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 3 Day 30
|
145.24 Titers
Interval 114.93 to 183.55
|
103.77 Titers
Interval 81.94 to 131.41
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 4 Day 1
|
114.78 Titers
Interval 76.28 to 172.72
|
96.28 Titers
Interval 63.5 to 145.97
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 4 Day 30
|
881.94 Titers
Interval 662.06 to 1174.84
|
924.82 Titers
Interval 706.73 to 1210.21
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 5 Day 1
|
41.89 Titers
Interval 28.38 to 61.83
|
39.52 Titers
Interval 26.73 to 58.44
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 5 Day 30
|
183.10 Titers
Interval 128.24 to 261.43
|
222.18 Titers
Interval 154.84 to 318.81
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6A Day 1
|
71.43 Titers
Interval 44.92 to 113.61
|
46.57 Titers
Interval 29.58 to 73.32
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6A Day 30
|
2321.06 Titers
Interval 1632.43 to 3300.19
|
2798.09 Titers
Interval 2064.22 to 3792.87
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19A Day 1
|
498.71 Titers
Interval 352.76 to 705.03
|
480.66 Titers
Interval 348.91 to 662.17
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19A Day 30
|
2078.60 Titers
Interval 1650.03 to 2618.48
|
1861.84 Titers
Interval 1480.24 to 2341.81
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19F Day 1
|
145.50 Titers
Interval 97.41 to 217.32
|
234.63 Titers
Interval 168.86 to 362.02
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19F Day 30
|
919.31 Titers
Interval 690.56 to 1223.83
|
961.71 Titers
Interval 747.2 to 1237.79
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 22F Day 1
|
173.09 Titers
Interval 107.99 to 277.44
|
120.52 Titers
Interval 73.92 to 196.49
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 22F Day 30
|
1761.25 Titers
Interval 1255.38 to 2470.97
|
107.83 Titers
Interval 64.66 to 179.8
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 23F Day 1
|
69.60 Titers
Interval 47.54 to 101.91
|
48.74 Titers
Interval 31.54 to 75.32
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 23F Day 30
|
846.33 Titers
Interval 617.56 to 1159.85
|
572.82 Titers
Interval 382.77 to 857.23
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 33F Day 1
|
1950.86 Titers
Interval 1369.3 to 2779.43
|
2093.00 Titers
Interval 1416.63 to 3092.3
|
|
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 33F Day 30
|
7856.78 Titers
Interval 5750.01 to 10735.45
|
2572.78 Titers
Interval 1800.33 to 3676.67
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.
The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 1
|
4.16 GMFR
Interval 3.09 to 5.58
|
3.33 GMFR
Interval 2.61 to 4.25
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 3
|
5.06 GMFR
Interval 3.92 to 6.54
|
3.24 GMFR
Interval 2.61 to 4.02
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 4
|
6.59 GMFR
Interval 4.52 to 9.6
|
7.94 GMFR
Interval 5.53 to 11.4
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 5
|
3.94 GMFR
Interval 3.01 to 5.16
|
4.95 GMFR
Interval 3.65 to 6.71
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6A
|
25.19 GMFR
Interval 16.41 to 38.68
|
43.85 GMFR
Interval 27.28 to 70.49
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6B
|
11.83 GMFR
Interval 8.03 to 17.44
|
14.74 GMFR
Interval 9.85 to 22.07
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 7F
|
4.77 GMFR
Interval 3.21 to 7.11
|
7.59 GMFR
Interval 5.03 to 11.44
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 9V
|
5.79 GMFR
Interval 4.19 to 7.99
|
5.79 GMFR
Interval 4.1 to 8.17
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 14
|
2.52 GMFR
Interval 1.86 to 3.42
|
1.89 GMFR
Interval 1.47 to 2.42
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 18C
|
8.14 GMFR
Interval 5.8 to 11.42
|
4.93 GMFR
Interval 3.61 to 6.74
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19A
|
4.14 GMFR
Interval 3.1 to 5.53
|
3.83 GMFR
Interval 2.94 to 5.0
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19F
|
5.55 GMFR
Interval 3.98 to 7.74
|
4.02 GMFR
Interval 3.11 to 5.19
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 22F
|
8.88 GMFR
Interval 5.44 to 14.48
|
0.85 GMFR
Interval 0.61 to 1.19
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 23F
|
10.41 GMFR
Interval 7.18 to 15.1
|
9.58 GMFR
Interval 6.47 to 14.19
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 33F
|
3.91 GMFR
Interval 2.76 to 5.54
|
1.03 GMFR
Interval 0.88 to 1.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 after vaccinationPopulation: Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).
Outcome measures
| Measure |
V114
n=127 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13™
n=126 Participants
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 1
|
40.7 Percentage of Participants
Interval 31.73 to 50.11
|
33.6 Percentage of Participants
Interval 25.01 to 43.12
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 3
|
53.8 Percentage of Participants
Interval 44.39 to 63.1
|
39.3 Percentage of Participants
Interval 30.19 to 48.96
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 4
|
44.1 Percentage of Participants
Interval 34.94 to 53.5
|
54.9 Percentage of Participants
Interval 45.23 to 64.25
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 5
|
44.9 Percentage of Participants
Interval 35.75 to 54.34
|
50.4 Percentage of Participants
Interval 40.88 to 59.98
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6A
|
71.8 Percentage of Participants
Interval 62.73 to 79.72
|
77.0 Percentage of Participants
Interval 68.13 to 84.39
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 6B
|
62.7 Percentage of Participants
Interval 53.33 to 71.44
|
67.0 Percentage of Participants
Interval 57.44 to 75.56
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 7F
|
41.0 Percentage of Participants
Interval 32.02 to 50.5
|
50.0 Percentage of Participants
Interval 40.4 to 59.6
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 9V
|
47.9 Percentage of Participants
Interval 38.54 to 57.29
|
44.6 Percentage of Participants
Interval 35.24 to 54.33
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 14
|
18.6 Percentage of Participants
Interval 12.07 to 26.86
|
15.9 Percentage of Participants
Interval 9.72 to 24.0
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 18C
|
54.2 Percentage of Participants
Interval 44.82 to 63.44
|
43.4 Percentage of Participants
Interval 34.07 to 53.01
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19A
|
37.3 Percentage of Participants
Interval 28.56 to 46.67
|
37.2 Percentage of Participants
Interval 28.26 to 46.76
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 19F
|
40.2 Percentage of Participants
Interval 31.22 to 49.64
|
38.1 Percentage of Participants
Interval 29.08 to 47.67
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 22F
|
50.4 Percentage of Participants
Interval 41.03 to 59.8
|
9.8 Percentage of Participants
Interval 5.01 to 16.89
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 23F
|
61.0 Percentage of Participants
Interval 51.61 to 69.86
|
52.2 Percentage of Participants
Interval 42.61 to 61.7
|
|
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
Serotype 33F
|
38.1 Percentage of Participants
Interval 29.35 to 47.53
|
6.3 Percentage of Participants
Interval 2.55 to 12.45
|
Adverse Events
V114
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
Prevnar 13®
Serious events: 2 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=127 participants at risk
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13®
n=126 participants at risk
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/127 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
0.79%
1/126 • Number of events 1 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/127 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
0.79%
1/126 • Number of events 1 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
Other adverse events
| Measure |
V114
n=127 participants at risk
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1.
|
Prevnar 13®
n=126 participants at risk
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
|
|---|---|---|
|
General disorders
Fatigue
|
18.1%
23/127 • Number of events 27 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
19.0%
24/126 • Number of events 30 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
General disorders
Injection site erythema
|
9.4%
12/127 • Number of events 12 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
7.9%
10/126 • Number of events 10 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
General disorders
Injection site pain
|
57.5%
73/127 • Number of events 78 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
46.0%
58/126 • Number of events 61 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
General disorders
Injection site swelling
|
15.7%
20/127 • Number of events 21 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
6.3%
8/126 • Number of events 8 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
7/127 • Number of events 7 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
8.7%
11/126 • Number of events 15 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.7%
20/127 • Number of events 23 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
11.1%
14/126 • Number of events 15 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
|
Nervous system disorders
Headache
|
13.4%
17/127 • Number of events 20 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
15.9%
20/126 • Number of events 30 • Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER