65 and older, any sex, with Pneumococcal Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With an Adverse Event (AE)Primary· Up to Day 44 after vaccination
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.
Group
Value
95% CI
V114
68.5
Prevnar 13™
64.3
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)Primary· Up to Day 5 after vaccination
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Erythema/Redness
Group
Value
95% CI
V114
7.9
Prevnar 13™
7.1
Swelling
Group
Value
95% CI
V114
14.2
Prevnar 13™
6.3
Tenderness/Pain
Group
Value
95% CI
V114
55.1
Prevnar 13™
44.4
Percentage of Participants With a Solicited Systemic Adverse Event (AE)Primary· Up to Day 14 after vaccination
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
Fatigue
Group
Value
95% CI
V114
18.1
Prevnar 13™
19.0
Arthralgia
Group
Value
95% CI
V114
5.5
Prevnar 13™
8.7
Myalgia
Group
Value
95% CI
V114
15.7
Prevnar 13™
11.1
Headache
Group
Value
95% CI
V114
13.4
Prevnar 13™
15.9
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)Primary· Baseline (Day 1) and Day 30 after vaccination
The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.
Serotype 1 Day 1
Group
Value
95% CI
V114
1.11
0.85 – 1.45
Prevnar 13™
1.27
.98 – 1.64
Serotype 1 Day 30
Group
Value
95% CI
V114
3.31
2.60 – 4.23
Prevnar 13™
3.42
2.61 – 4.47
Serotype 3 Day 1
Group
Value
95% CI
V114
0.19
0.15 – 0.23
Prevnar 13™
0.19
0.15 – 0.24
Serotype 3 Day 30
Group
Value
95% CI
V114
0.72
0.57 – 0.91
Prevnar 13™
0.46
0.36 – 0.58
Serotype 4 Day 1
Group
Value
95% CI
V114
0.32
0.25 – 0.41
Prevnar 13™
0.33
0.26 – 0.43
Serotype 4 Day 30
Group
Value
95% CI
V114
1.13
0.88 – 1.45
Prevnar 13™
1.15
0.88 – 1.51
Serotype 5 Day 1
Group
Value
95% CI
V114
1.31
1.01 – 1.70
Prevnar 13™
1.48
1.14 – 1.91
Serotype 5 Day 30
Group
Value
95% CI
V114
2.69
2.05 – 3.53
Prevnar 13™
3.67
2.75 – 4.90
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)Primary· Baseline (Day 1) and Day 30 after vaccination
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.
Serotype 1
Group
Value
95% CI
V114
2.98
2.39 – 3.73
Prevnar 13™
2.70
2.17 – 3.35
Serotype 3
Group
Value
95% CI
V114
3.14
2.54 – 3.88
Prevnar 13™
2.03
1.78 – 2.33
Serotype 4
Group
Value
95% CI
V114
3.37
2.66 – 4.26
Prevnar 13™
3.28
2.73 – 3.95
Serotype 5
Group
Value
95% CI
V114
2.14
1.82 – 2.50
Prevnar 13™
2.39
1.97 – 2.91
Serotype 6A
Group
Value
95% CI
V114
7.09
5.71 – 8.79
Prevnar 13™
8.24
6.39 – 10.62
Serotype 6B
Group
Value
95% CI
V114
5.20
4.19 – 6.46
Prevnar 13™
4.92
3.90 – 6.22
Serotype 7F
Group
Value
95% CI
V114
2.97
2.44 – 3.63
Prevnar 13™
3.03
2.46 – 3.74
Serotype 9V
Group
Value
95% CI
V114
2.98
2.42 – 3.67
Prevnar 13™
2.57
2.18 – 3.05
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)Primary· Baseline (Day 1) and Day 30 after vaccination
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.
Serotype 1
Group
Value
95% CI
V114
32.8
24.45 – 41.98
Prevnar 13™
26.5
18.77 – 35.45
Serotype 3
Group
Value
95% CI
V114
36.1
27.53 – 45.45
Prevnar 13™
17.1
10.77 – 25.16
Serotype 4
Group
Value
95% CI
V114
36.1
27.53 – 45.45
Prevnar 13™
35.9
27.24 – 45.29
Serotype 5
Group
Value
95% CI
V114
19.3
12.66 – 27.58
Prevnar 13™
23.9
16.53 – 32.70
Serotype 6A
Group
Value
95% CI
V114
64.7
55.42 – 73.24
Prevnar 13™
65.0
55.59 – 73.55
Serotype 6B
Group
Value
95% CI
V114
54.6
45.24 – 63.77
Prevnar 13™
46.2
36.90 – 55.61
Serotype 7F
Group
Value
95% CI
V114
31.1
22.93 – 40.23
Prevnar 13™
33.3
24.89 – 42.64
Serotype 9V
Group
Value
95% CI
V114
35.3
26.76 – 44.58
Prevnar 13™
23.9
16.53 – 32.70
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)Secondary· Baseline (Day 1) and Day 30 after vaccination
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).
Serotype 1 Day 1
Group
Value
95% CI
V114
20.30
14.87 – 27.70
Prevnar 13™
24.24
17.24 – 33.12
Serotype 1 Day 30
Group
Value
95% CI
V114
109.25
79.47 – 150.19
Prevnar 13™
91.53
65.77 – 127.37
Serotype 3 Day 1
Group
Value
95% CI
V114
23.37
17.56 – 31.09
Prevnar 13™
26.71
19.84 – 35.96
Serotype 3 Day 30
Group
Value
95% CI
V114
145.24
114.93 – 183.55
Prevnar 13™
103.77
81.94 – 131.41
Serotype 4 Day 1
Group
Value
95% CI
V114
114.78
76.28 – 172.72
Prevnar 13™
96.28
63.50 – 145.97
Serotype 4 Day 30
Group
Value
95% CI
V114
881.94
662.06 – 1174.84
Prevnar 13™
924.82
706.73 – 1210.21
Serotype 5 Day 1
Group
Value
95% CI
V114
41.89
28.38 – 61.83
Prevnar 13™
39.52
26.73 – 58.44
Serotype 5 Day 30
Group
Value
95% CI
V114
183.10
128.24 – 261.43
Prevnar 13™
222.18
154.84 – 318.81
Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)Secondary· Baseline (Day 1) and Day 30 after vaccination
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).
Serotype 1
Group
Value
95% CI
V114
4.16
3.09 – 5.58
Prevnar 13™
3.33
2.61 – 4.25
Serotype 3
Group
Value
95% CI
V114
5.06
3.92 – 6.54
Prevnar 13™
3.24
2.61 – 4.02
Serotype 4
Group
Value
95% CI
V114
6.59
4.52 – 9.60
Prevnar 13™
7.94
5.53 – 11.40
Serotype 5
Group
Value
95% CI
V114
3.94
3.01 – 5.16
Prevnar 13™
4.95
3.65 – 6.71
Serotype 6A
Group
Value
95% CI
V114
25.19
16.41 – 38.68
Prevnar 13™
43.85
27.28 – 70.49
Serotype 6B
Group
Value
95% CI
V114
11.83
8.03 – 17.44
Prevnar 13™
14.74
9.85 – 22.07
Serotype 7F
Group
Value
95% CI
V114
4.77
3.21 – 7.11
Prevnar 13™
7.59
5.03 – 11.44
Serotype 9V
Group
Value
95% CI
V114
5.79
4.19 – 7.99
Prevnar 13™
5.79
4.10 – 8.17
Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)Secondary· Baseline (Day 1) and Day 30 after vaccination
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).
Serotype 1
Group
Value
95% CI
V114
40.7
31.73 – 50.11
Prevnar 13™
33.6
25.01 – 43.12
Serotype 3
Group
Value
95% CI
V114
53.8
44.39 – 63.10
Prevnar 13™
39.3
30.19 – 48.96
Serotype 4
Group
Value
95% CI
V114
44.1
34.94 – 53.50
Prevnar 13™
54.9
45.23 – 64.25
Serotype 5
Group
Value
95% CI
V114
44.9
35.75 – 54.34
Prevnar 13™
50.4
40.88 – 59.98
Serotype 6A
Group
Value
95% CI
V114
71.8
62.73 – 79.72
Prevnar 13™
77.0
68.13 – 84.39
Serotype 6B
Group
Value
95% CI
V114
62.7
53.33 – 71.44
Prevnar 13™
67.0
57.44 – 75.56
Serotype 7F
Group
Value
95% CI
V114
41.0
32.02 – 50.50
Prevnar 13™
50.0
40.40 – 59.60
Serotype 9V
Group
Value
95% CI
V114
47.9
38.54 – 57.29
Prevnar 13™
44.6
35.24 – 54.33
Adverse events — posted to ClinicalTrials.gov
Time frame: Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05158140 — Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adu
· Phase 3
· completed
NCT04633226 — Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
· Phase 3
· completed
NCT04193215 — V114 and Acute Otitis Media (V114-032/PNEU-ERA)
· Phase 3
· completed
NCT04384107 — Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
· Phase 3
· completed
NCT03921424 — Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 14 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02573181.