Title: A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) in healthy Indian adults(Covishield 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

Safety Cohort: Covishield (SII-ChAdOx1 nCoV-19) OR Placebo

Immunogenicity Cohort: Covishield (SII-ChAdOx1 nCoV-19) OR Oxford/AZ-ChAdOx1 nCoV-19

Condition: Prevention of COVID-19

Objectives: a. To assess the Safety Covishield
b. To assess immunogenicity of Covishield in comparison with the Oxford/AZChAdOx1 nCoV-19 vaccine by IgG ELISA assay.

Study Initiation date: 26-Aug-2020

Study population: 1600 healthy volunteers

Study duration: 7 months

Current status of the study: Ongoing - 156 participants recruited


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