COVID-19 Clinical Trial
Official title:
Safety, Immunogenicity, and Batch Consistency of a Single Dose of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Chinese Healthy Adults Aged 18 Years and Above: a Randomized, Double-blind, Parallel-controlled Clinical Trial
This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)
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