Serum Institute of India Gets CDSCO Panel Nod To Conduct Phase II/III CT of Typhoid Conjugate Vaccine Bivalent
New Delhi: Noting the phase I clinical trial report presented by the vaccine major Serum Institute of India, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended approval to conduct Phase II/III clinical trials of typhoid conjugate vaccine (bivalent) as per the presented protocol.
However, this nod is subject to the condition that the firm should submit a Phase II study report along with a Data and Safety Monitoring Board (DSMB) review for approval before initiation of the Phase III study.
This came after Serum Institute of India presented the Phase I clinical trial report along with Phase II/III clinical trial protocol titled, “A Phase II/III, double-blind, randomized, active-controlled, multicentric study to evaluate the safety, immunogenicity and lot-to-lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years.”
The committee noted the safety results from the Phase I clinical trial report.
Typhoid fever is a bacterial infection that can spread throughout the body, affecting many organs. Without prompt treatment, it can cause serious complications and be fatal. It's caused by a bacterium called Salmonella typhi, which is related to the bacteria that cause salmonella food poisoning.
Typhoid conjugate vaccines (TCVs) are preferentially recommended by WHO because of their improved performance, single dose, and suitability for younger children. TCVs provide strong protection for at least 4 years, require only one dose, and are safe and effective for children older than 6 months of age.
At the recent SEC meeting for vaccine held on 18th December 2024, the expert panel reviewed the Phase I clinical trial report along with the Phase II/III clinical trial protocol titled, “A Phase II/III, double-blind, randomized, active-controlled, multicentric study to evaluate the safety, immunogenicity, and lot-to-lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years."
Furthermore, after detailed deliberation, the committee recommended the approval to conduct Phase II/III clinical trials as per the presented protocol, with the condition that the firm should submit a Phase II study report along with DSMB review for approval before initiation of the Phase III study.
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