COVID-19 Clinical Trial
Official title:
A Two-part, Phase I/II, Randomized, Observer-blinded, Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Recombinant ZR202-CoV and ZR202a-CoV Vaccines Administered at 0 and 28 Days as Compared to Comirnaty ®, and of a Booster Dose of ZR202a-CoV Vaccine in Healthy Adults.
For Phase 1 only. Additional information will be provided when Phase 2 is implemented. This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults. Part 1: A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study. The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
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