Submit complete Phase-I CT report: CDSCO Panel Tells Biological E on Bivalent Typhoid and Paratyphoid A Conjugate Vaccine
New Delhi: Reviewing the interim Phase-I clinical trial report of Typhoid and Paratyphoid A Conjugate Vaccine Bivalent, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine major Biological E to submit a complete Phase-I clinical trial report conducted in Europe for further deliberation of the proposal.
This came after the vaccine major Biological E presented an interim Phase-I clinical trial report conducted in Europe along with the Phase-II Clinical Trial Protocol titled “A prospective multicentre, observer-blind, Phase-II study to evaluate the safety and immunogenicity of Biological E’s Bivalent Typhoid and Paratyphoid A conjugate vaccine when administered to healthy adults, children/adolescents and infants/ toddlers in India”.
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.
At the recent SEC meeting for Vaccine held on June 25, 2024, the expert panel reviewed the interim Phase-I clinical trial report conducted in Europe along with the Phase-II Clinical Trial Protocol titled “A prospective multicentre, observer-blind, Phase-II study to evaluate the safety and immunogenicity of Biological E’s Bivalent Typhoid and Paratyphoid A conjugate vaccine when administered to healthy adults, children/ adolescents and infants/toddlers in India”.
After detailed deliberation, the committee recommended submitting a complete Phase-I clinical trial report conducted in Europe for further deliberation of the proposal.
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