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