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Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older

NCT04798027 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-09-11

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 mRNA vaccine formulation 1

Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 mRNA vaccine formulation 2

Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

BIOLOGICAL

SARS-CoV-2 mRNA vaccine formulation 3

Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection

BIOLOGICAL

Placebo (0.9% normal saline)

Pharmaceutical form: Liquid Route of administration: Intramuscular injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2022-06-27
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Honduras

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798027 on ClinicalTrials.gov