Clinical Trial Info

Phase 3 Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008)

Authored by
Staff

The primary objectives of the Phase 3 study are:

To assess, in 37,430 participants who are severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) naïve, the clinical efficacy of the SARS-CoV-2 vaccines for the prevention of symptomatic COVID-19 occurring ≥ 14 days after the second injection.

To assess the safety of the SARS-CoV-2 vaccines compared to placebo throughout the study.

The key secondary objectives of the study are to assess, in SARS-CoV-2 naïve participants, the efficacy of the SARS-CoV-2 vaccines against:

SARS-CoV-2 infection occurring ≥ 14 days after the second injection.

Severe disease occurring ≥ 14 days after the second injection.

Asymptomatic infection and symptomatic COVID-19 occurring ≥ 14 days after the first injection.