Design protocol as Phase III CT for 1 to more than 50 years age group: CDSCO panel tells Bharat Biotech on JE vaccine
New Delhi: In response to the proposal presented by the vaccine maker Bharath Biotech to conduct the Phase IV clinical trial of the Japanese Encephalitis Vaccine inactivated (Adsorded, Human), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should design the protocol as Phase III clinical trial for the proposed age group of 1year to more than 50 years.
This came after the firm presented its proposal for a grant of permission for the conduct of a Phase IV clinical trial of the Japanese Encephalitis Vaccine, inactivated (Adsorbed, Human) at the age group of 1 year to more than 50 years.
Japanese Encephalitis is an infection found in Asia and the West Pacific that can cause brain swelling.
Japanese encephalitis virus is spread to people through the bite of an infected mosquito. Most people who get infected experience mild or no symptoms. In people who develop severe disease, early symptoms include fever, headache, and vomiting. These symptoms may be followed by disorientation, coma, and seizures.
Japanese Encephalitis Vaccine inactivated (Adsorded, Human), indicated for active immunization against Japanese encephalitis in adults, adolescents, children, and infants aged 2 months and older.
At the recent SEC meeting for Vaccine held on 27th June 2023, the expert panel reviewed the proposal presented by vaccine maker Bharath Biotech for the grant of permission for the conduct of a Phase IV clinical trial of the Japanese Encephalitis Vaccine, inactivated (Adsorbed, Human) at the age group of 1 year to more than 50 years.
After detailed deliberation, the committee recommended that the firm should design the protocol as a Phase III clinical trial for the proposed age group.
Accordingly, the expert panel suggested that the firm is required to submit a revised protocol for further deliberation.
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