CDSCO Panel Approves Novo Medi Sciences' Phase III Booster Study of PCV13 Pneumococcal Vaccine in Infants

New Delhi: Reviewing the revised Phase III clinical trial protocol for booster dose administration of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) in infants, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Novo Medi Sciences for conducting the study as per the presented protocol.

This came after Novo Medi Sciences Private Limited submitted the amended Phase III clinical trial protocol titled, “A prospective, randomized, double-blind, multi-center, Phase III study to assess and compare the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in healthy Indian subjects.”

13-valent Pneumococcal Polysaccharide Conjugate Vaccine is a vaccine that protects against invasive pneumococcal disease and pneumonia caused by 13 specific types of Streptococcus pneumoniae bacteria.

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine.

At the recent SEC meeting on vaccines, the expert panel deliberated on the revised booster dose protocol presented by Novo Medi Sciences Private Limited.

After detailed deliberation, the committee recommended the conduct of the study as per the presented protocol.