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.”
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