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NCT04798027 · ClinicalTrials.gov registry record · Phase 1
Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 182
- Enrollment target
NCT04798027: Clinical Trial Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04798027 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 182 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798027, a Phase 1 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 182 participants
- Enrollment target
Study Summary
The primary objectives of the study are: * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: * To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. * To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection. * To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.
Primary Outcome
AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported
Interventions
- BIOLOGICAL SARS-CoV-2 mRNA vaccine formulation 1
- BIOLOGICAL SARS-CoV-2 mRNA vaccine formulation 2
- BIOLOGICAL SARS-CoV-2 mRNA vaccine formulation 3
- BIOLOGICAL Placebo (0.9% normal saline)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 1 |
Why NCT04798027 stopped before completion
NCT04798027 is an interventional study that assigns participants to a tested intervention. The registered 182 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 (203% higher).
The record links to 0 conditions, and to 4 interventions - of which SARS-CoV-2 mRNA vaccine formulation 1 is the first listed.
NCT04798027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04798027 about?
NCT04798027 is a clinical study titled "Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older". The primary objectives of the study are: * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secon...
What is the current status of trial NCT04798027?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2021-03-12. Estimated completion is 2022-06-27.
What interventions are being tested in trial NCT04798027?
The interventions under investigation include: SARS-CoV-2 mRNA vaccine formulation 1 (BIOLOGICAL), SARS-CoV-2 mRNA vaccine formulation 2 (BIOLOGICAL), SARS-CoV-2 mRNA vaccine formulation 3 (BIOLOGICAL), Placebo (0.9% normal saline) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04798027?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04798027's enrollment target sits among peer trials
182 299th of 2000 higher than 1,702 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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