The Serum Institute of India (SII) has introduced two and three clinical trials of its COVID-19 vaccine to assess its protection and immune reaction in healthy Indian adults, ANI news firm reported.
The pharmaceutical product was approved by the Auditor-General of India (DCGI) earlier this month.
According to the report, a total of 1,600 participants over the age of 18 will be enrolled in the study, which will be conducted at 17 sites in India.
These sites feature Andhra Medical College in Visakhapatanam, Seth GS Medical College and KEM Hospital in Mumbai, BJ Medical College and Sassoon General Hospital in Pune, the All India Institute of Medical Sciences (AIIMS) in Delhi.
Of the total number of iciprants, according to the report, 400 will belong to the immunogenicity cohort and will be randomly allocated, in a ratio of 3: 1, to obtain VOCISHIELD or Oxford / AZ-ChAdOx1 nCoV-19.
The remaining participants will be assigned, in a ratio of 3: 1, to obtain COVISHIELD or placebo respectively.
According to the Clinical Trial Registry India, Covishield will be administered in two doses on the first day and day 29 at a dose of 0.5 ml intramuscularly.
“The placebo will be administered in two doses on days one and 29 scheduled intramuscularly,” he added.
A form of written consent must be completed through the participants and must be living in the domain meeting the needs of the protocol. Participants, according to the report, will be excluded if they have an acute illness with or without fever at the time of vaccine management.
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