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NCT05507450 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,271
- Enrollment target
NCT05507450: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT05507450 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,271 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (856% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05507450, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,271 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
Primary Outcome
A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL V181 High-Potency Level
- BIOLOGICAL V181 Mid-Potency Level
- BIOLOGICAL V181 Low-Potency Level
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,271 participants |
| Start Date | 2022-09-07 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 2 |
What the finished NCT05507450 record still lists
NCT05507450 is an interventional study that assigns participants to a tested intervention. Its 1,271 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (856% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05507450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05507450 about?
NCT05507450 is a clinical study titled "Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)". The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Po...
What is the current status of trial NCT05507450?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,271 participants. The study started on 2022-09-07. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT05507450?
The interventions under investigation include: Placebo (BIOLOGICAL), V181 High-Potency Level (BIOLOGICAL), V181 Mid-Potency Level (BIOLOGICAL), V181 Low-Potency Level (BIOLOGICAL).
Who is sponsoring clinical trial NCT05507450?
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 NCT05507450's enrollment target sits among peer trials
1,271 15th of 2000 higher than 1,986 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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