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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 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 182 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04798027
The ClinicalTrials.gov registry entry for NCT04798027 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which SARS-CoV-2 mRNA vaccine formulation 1 is the first listed.
NCT04798027 reports 0 study locations.
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.
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