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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 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,271 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05507450
The ClinicalTrials.gov registry entry for NCT05507450 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,271 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 4 interventions - of which Placebo is the first listed.
NCT05507450 reports 0 study locations.
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.
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