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NCT03950856 · ClinicalTrials.gov registry record · Phase 3
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,340
- Enrollment target
NCT03950856: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03950856 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 2,340 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03950856, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,340 participants
- Enrollment target
Study Summary
The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.
Primary Outcome
An adverse event (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 redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicite
Interventions
- DRUG V114
- DRUG Prevnar 13™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,340 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2020-04-03 |
| Phase | Phase 3 |
What the finished NCT03950856 record still lists
NCT03950856 is an interventional study that assigns participants to a tested intervention. Its 2,340 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 (203% higher).
The record links to 0 conditions, and to 2 interventions - of which V114 is the first listed.
NCT03950856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03950856 about?
NCT03950856 is a clinical study titled "Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)". The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-s...
What is the current status of trial NCT03950856?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,340 participants. The study started on 2019-06-12. Estimated completion is 2020-04-03.
What interventions are being tested in trial NCT03950856?
The interventions under investigation include: V114 (DRUG), Prevnar 13™ (DRUG).
Who is sponsoring clinical trial NCT03950856?
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 NCT03950856's enrollment target sits among peer trials
2,340 92nd of 2000 higher than 1,909 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
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