Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03893448 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,720
- Enrollment target
NCT03893448: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03893448 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,720 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03893448, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,720 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL RotaTeq™
- BIOLOGICAL Pentacel™
- BIOLOGICAL RECOMBIVAX HB™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,720 participants |
| Start Date | 2019-06-19 |
| Est. Completion | 2021-05-24 |
| Phase | Phase 3 |
What the finished NCT03893448 record still lists
NCT03893448 is an interventional study that assigns participants to a tested intervention. Its 1,720 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 5 interventions - of which V114 is the first listed.
NCT03893448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03893448 about?
NCT03893448 is a clinical study titled "Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)". The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V...
What is the current status of trial NCT03893448?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,720 participants. The study started on 2019-06-19. Estimated completion is 2021-05-24.
What interventions are being tested in trial NCT03893448?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), RotaTeq™ (BIOLOGICAL), Pentacel™ (BIOLOGICAL), RECOMBIVAX HB™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT03893448?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03893448's enrollment target sits among peer trials
1,720 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06898034 · 1,725 participants
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
- NCT04291612 · 1,715 participants
Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
- NCT05303636 · 1,710 participants · Phase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
- NCT06413420 · 1,731 participants
SUNOSI® (Solriamfetol) Pregnancy Registry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI