Serum Institute of India Gets CDSCO Panel Nod To study Meningococcal Polysaccharide Conjugate Vaccine Freeze-Dried
New Delhi: The vaccine major Serum Institute of India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical trial of Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried).
However, this nod is subject to the condition that the firm should include more sites covering all geographical areas
This came after Serum Institute of India presented the Phase III clinical trial report of Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried) of a study titled "A Phase III, randomized, double-blind, controlled, multi-center study to compare immunogenicity and safety of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) with that of licensed Meningococcal ACWY Vaccine Menactra in healthy Indian children of 9 months to 17 years of age".
Vaccines can help prevent meningococcal disease, any illness caused by Neisseria meningitidis bacteria. Meningococcal polysaccharide conjugate vaccine is an active immunizing agent used to prevent infection by certain groups of meningococcal bacteria. The vaccine works by causing body to produce its own protection (antibodies) against the bacteria.
At the recent SEC meeting for vaccine held on July 31, 2024, the expert panel reviewed the Phase III clinical trial report of Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried) presented by Serum Institute of India.
After detailed deliberation, the committee recommended approval to conduct the Phase-III clinical trial as per the presented protocol, with the condition of including more sites covering all geographical areas.
