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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-09T18:00:34+05:30 | Updated On 9 Dec 2024 6:00 PM IST

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.

At the recent SEC meeting for vaccine held on November 26, 2024, the expert panel reviewed the report of the Phase I clinical trial of Typhoid and Paratyphoid A bivalent vaccine conducted in Europe along with the 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."

After detailed deliberation, the committee recommended that the firm should submit a revised protocol for the conduct of Phase I clinical trial in India to CDSCO for further deliberation.

Also Read: Intas Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Anti-cancer Drug Pertuzumab

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751