Revise Phase IV CT: CDSCO panel tells Bharat Biotech over Typhoid (Vi Capsular Polysaccharide) Tetanus Toxoid Conjugate Vaccine

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has directed the vaccine maker Bharat Biotech to revise the Phase IV clinical trial protocol of the Typhoid (Vi Capsular Polysaccharide) Tetanus Toxoid Conjugate Vaccine.

This came after the firm presented the Phase IV clinical trial protocol of Typhoid (Vi Capsular Polysaccharide) Tetanus Toxoid Conjugate Vaccine.

Typhoid Vi Capsular Polysaccharide-Tetanus Toxoid Conjugate Vaccine is also known as Typbar-TCV. Typbar-TCV is liquid vaccine presented in single and multi-dose vial & single dose as Pre Fill Syringe. It is Active Immunizing Agent. Typbar-TCV is indicated for active immunization against Salmonella typhi infection in adults, children and infants of age ≥6 months and above.

Typhoid fever is a very common and serious bacterial disease caused by Salmonella typhi. All conjugate vaccine studies have shown that the efficacy and immunogenicity are higher than those of the plain Vi polysaccharide vaccine. In the manufacturing of Typbar-TCV the Vi-polysaccharide has been conjugated with a nontoxic Tetanus Toxoid. This innovative vaccine has a higher immunogenicity response and is T-cell dependent, which induces Vi antibodies that neutralize Vi antigen and hence prevents the infection.

Typhoid conjugate vaccine containing Vi polysaccharide conjugated to tetanus toxoid (Typbar TCV, Bharat Biotech International, Hyderabad, India) is a single-dose parental vaccine prequalified by WHO in 2017 and recommended for children as young as 6 months of age as well as for adults.

At the recent SEC meeting for vaccines, the expert panel reviewed the Phase IV clinical trial protocol of Typhoid (Vi Capsular Polysaccharide) Tetanus Toxoid Conjugate Vaccine.

After detailed deliberation, the committee recommended to revise the protocol as below;

1) Title of the clinical trial to be changed as Phase-III.

2) (a) Past history of typhoid disease in last 5 years

(b) History of immunization with Typhoid vaccine in last 5 years should be included in the exclusion criteria.

"Accordingly, the firm should submit revised protocol to CDSCO for further consideration," stated the committee

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