50 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 a Solicited Injection-site Adverse EventPrimary· Up to Day 5 postvaccination
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.
Injection site erythema
Group
Value
95% CI
V114
9.0
Prevnar 13™
11.3
Injection site pain
Group
Value
95% CI
V114
54.0
Prevnar 13™
42.3
Injection site swelling
Group
Value
95% CI
V114
12.5
Prevnar 13™
11.2
Percentage of Participants With Solicited Systemic Adverse EventsPrimary· Up to Day 14 postvaccination
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.
Joint pain/arthralgia
Group
Value
95% CI
V114
5.3
Prevnar 13™
5.5
Tiredness/fatigue
Group
Value
95% CI
V114
17.4
Prevnar 13™
17.3
Headache
Group
Value
95% CI
V114
11.6
Prevnar 13™
13.0
Muscle pain/myalgia
Group
Value
95% CI
V114
15.4
Prevnar 13™
12.0
Percentage of Participants With a Vaccine-related Serious Adverse EventPrimary· Up to Month 6
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.
Group
Value
95% CI
V114
0.0
Prevnar 13™
0.0
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30Primary· Day 30
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).
Serotype 1 (Shared)
Group
Value
95% CI
V114
256.3
Prevnar 13™
322.6
Serotype 3 (Shared)
Group
Value
95% CI
V114
216.2
Prevnar 13™
135.1
Serotype 4 (Shared)
Group
Value
95% CI
V114
1125.6
Prevnar 13™
1661.6
Serotype 5 (Shared)
Group
Value
95% CI
V114
447.3
Prevnar 13™
563.5
Serotype 6A (Shared)
Group
Value
95% CI
V114
5407.2
Prevnar 13™
5424.5
Serotype 6B (Shared)
Group
Value
95% CI
V114
4011.7
Prevnar 13™
3258.2
Serotype 7F (Shared)
Group
Value
95% CI
V114
4617.3
Prevnar 13™
5880.6
Serotype 9V (Shared)
Group
Value
95% CI
V114
1817.3
Prevnar 13™
2232.9
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 SerotypesPrimary· Day 1 (Baseline) and Day 30
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 percenta
Serotype 22F (Unique to V114)
Group
Value
95% CI
V114
71.4
Prevnar 13™
14.3
Serotype 33F (Unique to V114)
Group
Value
95% CI
V114
56.7
Prevnar 13™
6.3
GMT of Serotype-specific OPA for Serotype 3 at Day 30Secondary· Day 30
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.
Group
Value
95% CI
V114
216.2
Prevnar 13™
135.1
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA ResponsesSecondary· Day 1 (Baseline) and Day 30
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.
Group
Value
95% CI
V114
70.2
Prevnar 13™
58.7
Geometric Mean Concentration of Serotype-specific IgG at Day 30Secondary· Day 30
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 "numbe
Serotype 1 (Shared)
Group
Value
95% CI
V114
5.30
Prevnar 13™
7.34
Serotype 3 (Shared)
Group
Value
95% CI
V114
0.96
Prevnar 13™
0.64
Serotype 4 (Shared)
Group
Value
95% CI
V114
1.88
Prevnar 13™
2.62
Serotype 5 (Shared)
Group
Value
95% CI
V114
4.57
Prevnar 13™
5.56
Serotype 6A (Shared)
Group
Value
95% CI
V114
7.21
Prevnar 13™
7.01
Serotype 6B (Shared)
Group
Value
95% CI
V114
8.60
Prevnar 13™
6.19
Serotype 7F (Shared)
Group
Value
95% CI
V114
6.18
Prevnar 13™
8.09
Serotype 9V (Shared)
Group
Value
95% CI
V114
4.77
Prevnar 13™
5.52
Geometric Mean Fold Rise in Serotype-specific OPASecondary· Day 1 (Baseline) and Day 30
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.
Serotype 1 (Shared)
Group
Value
95% CI
V114
14.3
12.5 – 16.4
Prevnar 13™
18.7
16.2 – 21.5
Serotype 3 (Shared)
Group
Value
95% CI
V114
7.7
7.0 – 8.6
Prevnar 13™
5.2
4.7 – 5.7
Serotype 4 (Shared)
Group
Value
95% CI
V114
17.8
15.7 – 20.3
Prevnar 13™
24.4
21.3 – 27.8
Serotype 5 (Shared)
Group
Value
95% CI
V114
12.3
10.7 – 14.2
Prevnar 13™
15.3
13.2 – 17.6
Serotype 6A (Shared)
Group
Value
95% CI
V114
13.0
11.4 – 14.9
Prevnar 13™
13.3
11.6 – 15.2
Serotype 6B (Shared)
Group
Value
95% CI
V114
26.3
22.4 – 30.8
Prevnar 13™
21.6
18.5 – 25.2
Serotype 7F (Shared)
Group
Value
95% CI
V114
12.0
10.3 – 13.9
Prevnar 13™
14.1
12.1 – 16.5
Serotype 9V (Shared)
Group
Value
95% CI
V114
5.3
4.8 – 6.0
Prevnar 13™
6.3
5.6 – 7.1
Geometric Mean Fold Rise in Serotype-specific IgGSecondary· Day 1 (Baseline) and Day 30
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.
Serotype 1 (Shared)
Group
Value
95% CI
V114
10.6
9.4 – 12.0
Prevnar 13™
14.7
13.1 – 16.6
Serotype 3 (Shared)
Group
Value
95% CI
V114
6.8
6.2 – 7.6
Prevnar 13™
4.7
4.2 – 5.1
Serotype 4 (Shared)
Group
Value
95% CI
V114
8.0
7.2 – 9.0
Prevnar 13™
11.2
10.0 – 12.5
Serotype 5 (Shared)
Group
Value
95% CI
V114
4.7
4.2 – 5.2
Prevnar 13™
5.8
5.2 – 6.5
Serotype 6A (Shared)
Group
Value
95% CI
V114
19.9
17.6 – 22.6
Prevnar 13™
19.7
17.4 – 22.3
Serotype 6B (Shared)
Group
Value
95% CI
V114
19.1
16.8 – 21.7
Prevnar 13™
13.8
12.3 – 15.6
Serotype 7F (Shared)
Group
Value
95% CI
V114
12.3
10.9 – 13.9
Prevnar 13™
15.8
13.9 – 18.0
Serotype 9V (Shared)
Group
Value
95% CI
V114
9.9
8.9 – 11.1
Prevnar 13™
11.1
9.9 – 12.4
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA TiterSecondary· Day 1 (Baseline) and Day 30
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.
Serotype 1 (Shared)
Group
Value
95% CI
V114
75.1
71.4 – 78.6
Prevnar 13™
77.7
74.0 – 81.0
Serotype 3 (Shared)
Group
Value
95% CI
V114
70.2
66.3 – 73.9
Prevnar 13™
58.7
54.5 – 62.7
Serotype 4 (Shared)
Group
Value
95% CI
V114
79.5
76.0 – 82.7
Prevnar 13™
84.8
81.6 – 87.6
Serotype 5 (Shared)
Group
Value
95% CI
V114
71.6
67.8 – 75.2
Prevnar 13™
75.3
71.6 – 78.8
Serotype 6A (Shared)
Group
Value
95% CI
V114
76.5
72.7 – 80.0
Prevnar 13™
74.9
71.1 – 78.5
Serotype 6B (Shared)
Group
Value
95% CI
V114
81.2
77.7 – 84.3
Prevnar 13™
79.2
75.6 – 82.4
Serotype 7F (Shared)
Group
Value
95% CI
V114
66.4
62.4 – 70.3
Prevnar 13™
72.4
68.5 – 76.1
Serotype 9V (Shared)
Group
Value
95% CI
V114
54.0
49.8 – 58.1
Prevnar 13™
60.0
55.9 – 64.1
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG ConcentrationSecondary· Day 1 (Baseline) and Day 30
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.
Serotype 1 (Shared)
Group
Value
95% CI
V114
73.1
69.4 – 76.7
Prevnar 13™
78.4
74.9 – 81.7
Serotype 3 (Shared)
Group
Value
95% CI
V114
61.6
57.5 – 65.5
Prevnar 13™
51.4
47.2 – 55.5
Serotype 4 (Shared)
Group
Value
95% CI
V114
65.0
61.0 – 68.9
Prevnar 13™
76.0
72.3 – 79.4
Serotype 5 (Shared)
Group
Value
95% CI
V114
45.1
41.0 – 49.2
Prevnar 13™
53.4
49.3 – 57.5
Serotype 6A (Shared)
Group
Value
95% CI
V114
83.5
80.3 – 86.4
Prevnar 13™
83.4
80.1 – 86.3
Serotype 6B (Shared)
Group
Value
95% CI
V114
82.8
79.5 – 85.8
Prevnar 13™
77.5
73.9 – 80.8
Serotype 7F (Shared)
Group
Value
95% CI
V114
73.5
69.7 – 77.0
Prevnar 13™
78.6
75.0 – 81.9
Serotype 9V (Shared)
Group
Value
95% CI
V114
69.6
65.7 – 73.3
Prevnar 13™
75.5
71.8 – 79.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
V114
Serious: 9/602 (1%)
Deaths: 1/604
PCV13
Serious: 13/600 (2%)
Deaths: 1/601
Serious adverse events (23 terms)
Reaction
System
V114
PCV13
Anaemia
Blood and lymphatic system disorders
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Angina unstable
Cardiac disorders
—
—
Arrhythmia
Cardiac disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Incarcerated umbilical hernia
Gastrointestinal disorders
—
—
Oesophagitis ulcerative
Gastrointestinal disorders
—
—
Death
General disorders
—
—
Diverticulitis
Infections and infestations
—
—
Viral infection
Infections and infestations
—
—
Meniscus injury
Injury, poisoning and procedural complications
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Gastrointestinal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Prostate cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
Publications & conference data
3 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 9 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: 26 April 2021
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/NCT03950622.