Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

  • STATUS
    Recruiting
  • participants needed
    440
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 28 March 2023
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Summary

The primary objectives of the study are:

  • To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group.
  • To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection.

The secondary objectives of the study are:

  • To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group.
  • To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group.
  • To describe the occurrence of virologically-confirmed COVID-19-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Description

The duration of each participant's participation in the study will be approximately 365 days post last injection

Details
Condition Covid 19
Age 18years - 100years
Treatment SARS-CoV-2 vaccine formulation 1 with adjuvant 1, SARS-CoV-2 vaccine formulation 1 with adjuvant 2, SARS-CoV-2 vaccine formulation 2 with adjuvant 1, SARS-CoV-2 vaccine formulation 2 with adjuvant 2, SARS-CoV-2 vaccine formulation 2 without adjuvant, Placebo (0.9% normal saline)
Clinical Study IdentifierNCT04537208
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on28 March 2023

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