Title: A phase 3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of Covovax [sars-cov-2 recombinant spike protein nanoparticle vaccine (sars-cov-2 rs) with matrix-m1™ adjuvant] in Indian adults(Covovax study)

Sponsor: Serum Institute of India Private Limited (Siipl)

Co-Sponsor: Indian Council of Medical Research (ICMR)

Study Design: Observer -blind, Randomized, controlled, Multicentric Study

Intervention: COVOVAX OR Active controlled (Novavax- SARS-CoV-2 rS with MatrixM1™Adjuvant)

Condition: Prevention of COVID-19

Objectives: a. To assess the safety of COVOVAX in comparison with the Control vaccine (Novavax-SARS-CoV-2 rS with Matrix-M1™ Adjuvant)
b. To assess immunogenicity ofCOVOVAX in comparison with the Control vaccine by IgG ELISA assay

Study Initiation date: Not yet initiated 

Study population:1600 healthy individuals ≥ 18 years of age

Study duration: 9 months


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