NCT04798027

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

Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each participant's participation in the study was approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-12
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2021-03-15
• Last updated: 2025-09-11
• Results posted: 2023-12-15

Locations

21 sites across 4 countries: United States, Australia, Brazil, Honduras

Regulatory

• FDA-regulated drug study