According to sources, the Serum Institute of India has submitted an application to the Drugs Controller General of India to conduct Phase II/III human trials of a COVID-19 vaccine being developed by AstraZeneca and Oxford University, as reported in The Economic Times.
The randomised study will enroll 1600 healthy Indian adults to determine the safety and immunogenicity of the potential vaccine.
Initial trial results of the vaccine conducted in the UK have shown it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.
The firm plans to begin Phase II/III human trials in India in August.
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