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 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,720 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893448
The ClinicalTrials.gov registry entry for NCT03893448 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which V114 is the first listed.
NCT03893448 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.