At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 441 enrolled

Drug / intervention

CoV2 preS dTM-AF03 (low-dose) +5 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04537208

NCT04537208Phase 2Completed

Compare CT.gov

Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 3, 2020·Updated Sep 17, 2025

In Brief

A Phase 2 clinical trial evaluating CoV2 preS dTM-AF03 (low-dose), CoV2 preS dTM-AF03 (high-dose), and 4 other interventions for COVID-19 (Healthy Volunteers). Completed, enrolled 441 participants across 11 sites.

Detailed Summary

The primary objectives of the study were: * 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 coronavirus disease (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 virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCOVID-19 (Healthy Volunteers)

CountriesUnited States

CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished

202120222023202420252026

First PostedSep 2020

Enrollment StartSep 2020

Primary CompletionNov 2021

TodayJul 2026

First PostedSep 3, 2020

Enrollment StartSep 3, 2020

Primary CompletionNov 19, 2021

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 5.8 years ago