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NCT04569786 · ClinicalTrials.gov registry record · Phase 1
Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 232
- Enrollment target
NCT04569786: Clinical Trial Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04569786 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 232 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (287% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569786, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 232 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Solicited injection site AEs (injection site redness/erythema, pain, swelling) were ass
Interventions
- OTHER Placebo
- BIOLOGICAL V590
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2021-02-18 |
| Phase | Phase 1 |
Why NCT04569786 stopped before completion
NCT04569786 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (287% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04569786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04569786 about?
NCT04569786 is a clinical study titled "Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)". The primary objective of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respirator...
What is the current status of trial NCT04569786?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 232 participants. The study started on 2020-10-29. Estimated completion is 2021-02-18.
What interventions are being tested in trial NCT04569786?
The interventions under investigation include: Placebo (OTHER), V590 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04569786?
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 NCT04569786's enrollment target sits among peer trials
232 216th of 2000 higher than 1,784 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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