Adults 2 Months to 6 Months, 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 Solicited Injection-Site Adverse EventsPrimary· Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Injection site erythema
Group
Value
95% CI
V114
88.2
PCV13
89.3
Injection site induration
Group
Value
95% CI
V114
81.0
PCV13
81.2
Injection site pain
Group
Value
95% CI
V114
31.1
PCV13
24.0
Injection site swelling
Group
Value
95% CI
V114
75.8
PCV13
79.8
Percentage of Participants With Solicited Systemic Adverse EventsPrimary· Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
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 any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.
Decreased appetite
Group
Value
95% CI
V114
23.9
PCV13
24.3
Irritability
Group
Value
95% CI
V114
66.6
PCV13
60.7
Somnolence
Group
Value
95% CI
V114
55.9
PCV13
54.9
Urticaria
Group
Value
95% CI
V114
4.0
PCV13
4.3
Percentage of Participants With Vaccine-Related Serious Adverse EventsPrimary· ~1 month after Dose 4, up to a total of 14 months
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Group
Value
95% CI
V114
0.3
PCV13
0.3
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3Primary· 30 Days after Dose 3, up to a total of 11 months
The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
99.7
PCV13
100.0
Serotype 3 (Shared)
Group
Value
95% CI
V114
100.0
PCV13
97.7
Serotype 4 (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
Serotype 5 (Shared)
Group
Value
95% CI
V114
98.8
PCV13
100.0
Serotype 6A (Shared)
Group
Value
95% CI
V114
99.1
PCV13
100.0
Serotype 6B (Shared)
Group
Value
95% CI
V114
95.0
PCV13
98.8
Serotype 7F (Shared)
Group
Value
95% CI
V114
99.7
PCV13
100.0
Serotype 9V (Shared)
Group
Value
95% CI
V114
99.7
PCV13
100.0
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3Primary· 30 Days after Dose 3, up to a total of 11 months
The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
2.39
2.19 – 2.62
PCV13
3.95
3.61 – 4.32
Serotype 3 (Shared)
Group
Value
95% CI
V114
2.63
2.39 – 2.89
PCV13
1.42
1.29 – 1.56
Serotype 4 (Shared)
Group
Value
95% CI
V114
2.98
2.71 – 3.27
PCV13
3.54
3.23 – 3.89
Serotype 5 (Shared)
Group
Value
95% CI
V114
2.59
2.32 – 2.89
PCV13
3.35
3.00 – 3.74
Serotype 6A (Shared)
Group
Value
95% CI
V114
2.51
2.26 – 2.79
PCV13
4.45
4.00 – 4.94
Serotype 6B (Shared)
Group
Value
95% CI
V114
2.46
2.14 – 2.82
PCV13
4.17
3.63 – 4.79
Serotype 7F (Shared)
Group
Value
95% CI
V114
4.38
3.95 – 4.85
PCV13
5.22
4.71 – 5.78
Serotype 9V (Shared)
Group
Value
95% CI
V114
3.09
2.80 – 3.41
PCV13
3.55
3.22 – 3.92
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3Secondary· 30 days after Dose 3, up to a total of 11 months
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.
Serotype 22F (Unique to V114)
Group
Value
95% CI
V114
6.59
5.95 – 7.30
PCV13
0.06
0.06 – 0.07
Serotype 33F (Unique to V114)
Group
Value
95% CI
V114
1.85
1.60 – 2.14
PCV13
0.06
0.05 – 0.07
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4Secondary· 30 Days after Dose 4, up to a total of 14 months
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
99.7
PCV13
100.0
Serotype 3 (Shared)
Group
Value
95% CI
V114
100.0
PCV13
96.7
Serotype 4 (Shared)
Group
Value
95% CI
V114
99.7
PCV13
100.0
Serotype 5 (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
Serotype 6A (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
Serotype 6B (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
Serotype 7F (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
Serotype 9V (Shared)
Group
Value
95% CI
V114
100.0
PCV13
100.0
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4Secondary· 30 Days after Dose 4, up to a total of 14 months
The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
2.74
2.47 – 3.04
PCV13
5.19
4.68 – 5.77
Serotype 3 (Shared)
Group
Value
95% CI
V114
2.18
1.97 – 2.41
PCV13
1.28
1.15 – 1.41
Serotype 4 (Shared)
Group
Value
95% CI
V114
2.91
2.57 – 3.30
PCV13
3.18
2.81 – 3.59
Serotype 5 (Shared)
Group
Value
95% CI
V114
4.43
3.96 – 4.95
PCV13
6.65
5.95 – 7.43
Serotype 6A (Shared)
Group
Value
95% CI
V114
6.05
5.36 – 6.81
PCV13
9.41
8.35 – 10.60
Serotype 6B (Shared)
Group
Value
95% CI
V114
8.03
7.12 – 9.05
PCV13
10.88
9.66 – 12.26
Serotype 7F (Shared)
Group
Value
95% CI
V114
5.80
5.15 – 6.54
PCV13
7.15
6.35 – 8.05
Serotype 9V (Shared)
Group
Value
95% CI
V114
4.27
3.79 – 4.81
PCV13
5.18
4.60 – 5.83
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3Secondary· 30 Days after Dose 3, up to a total of 11 months
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
211.51
180.48 – 247.86
PCV13
322.44
275.23 – 377.76
Serotype 3 (Shared)
Group
Value
95% CI
V114
660.68
586.60 – 744.11
PCV13
471.43
418.48 – 531.08
Serotype 4 (Shared)
Group
Value
95% CI
V114
3984.87
3537.66 – 4488.62
PCV13
4118.16
3656.82 – 4637.70
Serotype 5 (Shared)
Group
Value
95% CI
V114
1241.69
1098.82 – 1403.14
PCV13
1358.43
1202.35 – 1534.79
Serotype 6A (Shared)
Group
Value
95% CI
V114
9124.96
7894.53 – 10547.16
PCV13
11956.64
10340.85 – 13824.91
Serotype 6B (Shared)
Group
Value
95% CI
V114
8416.19
7243.92 – 9778.18
PCV13
10421.94
8972.87 – 12105.02
Serotype 7F (Shared)
Group
Value
95% CI
V114
22324.41
19365.68 – 25735.19
PCV13
27396.28
23771.84 – 31573.33
Serotype 9V (Shared)
Group
Value
95% CI
V114
2725.29
2399.27 – 3095.62
PCV13
3338.40
2939.75 – 3791.11
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4Secondary· 30 Days after Dose 4, up to a total of 14 months
The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.
Serotype 1 (Shared)
Group
Value
95% CI
V114
453.42
327.21 – 628.32
PCV13
854.50
616.64 – 1184.10
Serotype 3 (Shared)
Group
Value
95% CI
V114
1444.00
1166.36 – 1787.72
PCV13
893.97
720.25 – 1109.58
Serotype 4 (Shared)
Group
Value
95% CI
V114
4531.52
3592.99 – 5715.21
PCV13
6264.94
4957.63 – 7916.97
Serotype 5 (Shared)
Group
Value
95% CI
V114
1853.08
1439.01 – 2386.30
PCV13
2151.95
1669.81 – 2773.30
Serotype 6A (Shared)
Group
Value
95% CI
V114
12553.06
10072.11 – 15645.13
PCV13
17476.24
13999.28 – 21816.75
Serotype 6B (Shared)
Group
Value
95% CI
V114
9218.64
7346.96 – 11567.14
PCV13
14041.53
11171.79 – 17648.42
Serotype 7F (Shared)
Group
Value
95% CI
V114
15451.96
12500.49 – 19100.31
PCV13
18039.04
14593.41 – 22298.22
Serotype 9V (Shared)
Group
Value
95% CI
V114
3259.24
2548.05 – 4168.93
PCV13
5050.89
3957.89 – 6445.73
Adverse events — posted to ClinicalTrials.gov
Time frame: Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
Publications & conference data
1 peer-reviewed publication 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
NCT03921424 — Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
· Phase 3
· completed
NCT04031846 — Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
· Phase 3
· completed
Other recruiting trials for Pneumococcal Infections
Currently open trials in the same condition.
NCT06822907 — Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
· Phase 4
· recruiting
NCT07017777 — A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infant
· Phase 3
· recruiting
NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i
· Phase 3
· active not recruiting
NCT06608199 — A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13
· Phase 3
· recruiting
NCT04945681 — Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People
· Phase 4
· active not recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005)
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
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: 28 July 2023
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/NCT04384107.