City-based Biological E Limited (BE), a vaccine and pharmaceutical company on Tuesday announced the publication of phase-III clinical trials results of 14-Valent Pneumococcal Conjugate Vaccine (PCV) (Pneubevax 14; BE-PCV-14), conducted in paediatric population (six to eight week age group). The study results have been accepted and published by Vaccine, a peer-reviewed international journal.
The company in an official release said that in this study, the immunogenicity and safety of the BE’s 14-Valent PCV containing two additional epidemiologically important serotypes (22F and 33F) were evaluated in infants, in comparison to the licensed comparator vaccine PCV-13.
Mahima Datla, Managing Director, Biological E Limited, said: “We are pleased to announce that our Phase-III clinical trial results for Pneubevax 14 have been published by the Vaccine Journal. We have reached a significant milestone in our ongoing fight against pneumococcal disease. Now we are one step closer to the finish line with our 14-Valent PCV Vaccine Pneubevax 14.”
This study, a single blind randomized active-controlled, was conducted at 12 sites across India in 1,290 healthy infants at six-10-14 weeks dosing schedule to assess immunogenic non-inferiority and safety of the vaccine, the pharma major further said adding that immunogenicity was assessed by measuring anti-Pneumococcal Capsular Polysaccharide (anti-PnCPS) IgG concentration and functional antibody titres through Opsonophagocytic Activity (OPA), one month after completing a three-dose schedule. Cross- protection against serotype 6A offered by serotype 6B was also assessed in this study.
