Clinical Trial: A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Immunogenicity
Study Type: INTERVENTIONAL
Official Title: A Phase 2/3, Randomized, Double-blinded , Parallel Controlled Trial to Evaluate the Immunogenicity, Safety and Efficacy of A Heterologous Booster Dose With COVID-19 mRNA Vaccines (Bivalent) , in
Brief Summary:
Primary Immunogenicity Objective?Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose.Primary Safety Objective?To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized…
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