Revise protocol for conducting Phase I CT in India: CDSCO Panel Tells Biological E on Typhoid and Paratyphoid A Bivalent Vaccine

New Delhi: Reviewing the Phase I clinical trial report of Typhoid and Paratyphoid A Bivalent Vaccine conducted in Europe, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Biological E to submit a revised protocol for the conduct of Phase I clinical trials in India.

This came after the firm presented the report of Phase I clinical trial of Typhoid and Paratyphoid A Bivalent Vaccine conducted in Europe along with revised Phase I/II clinical trial protocol titled "A prospective multicentre, observer blind, Phase I/II study to evaluate the safety and immunogenicity of Biological E's Bivalent Typhoid and Paratyphoid A conjugate vaccine when administered to healthy adults and children/adolescents infants/toddlers in India."

The committee reviewed the safety report of the Phase I clinical trial conducted in Europe.

Typhoid and paratyphoid (also known as typhoid and paratyphoid fever) are bacterial infections of the intestinal tract and bloodstream. The bacterium responsible for typhoid is called Salmonella typhi, and the bacterium responsible for paratyphoid is Salmonella paratyphi.

Earlier, the Medical Dialogue Team had reported that the committee recommended the firm to submit a complete Phase-I clinical trial report conducted in Europe for further deliberation of the proposal.