Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04498247 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 1
- Development phase
- 263
- Enrollment target
NCT04498247: Clinical Trial Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04498247 is a Phase 1 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 263 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (338% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04498247, a Phase 1 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 263 participants
- Enrollment target
Study Summary
The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
Primary Outcome
An 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. Injection site AEs of pain/tenderness, swelling, and redness/erythema were assessed.
Interventions
- OTHER Placebo
- BIOLOGICAL V591
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2020-08-27 |
| Est. Completion | 2021-03-05 |
| Phase | Phase 1 |
Why NCT04498247 stopped before completion
NCT04498247 is an interventional study that assigns participants to a tested intervention. The registered 263 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 (338% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04498247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04498247 about?
NCT04498247 is a clinical study titled "A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)". The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
What is the current status of trial NCT04498247?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 263 participants. The study started on 2020-08-27. Estimated completion is 2021-03-05.
What interventions are being tested in trial NCT04498247?
The interventions under investigation include: Placebo (OTHER), V591 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04498247?
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 NCT04498247's enrollment target sits among peer trials
263 158th of 2000 higher than 1,842 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04067336 · 263 participants · Phase 1
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
- NCT06234423 · 263 participants · Phase 1
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
- NCT06724627 · 263 participants · NA
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
- NCT04101669 · 264 participants · NA
RESET System Pivotal Trial (Rev F)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI