The phase III clinical trials of Biological E’s (BE)’s 14-Valent Pneumococcal Conjugate Vaccine (PCV), Pneubevax14 (BE-PCV-14) conducted in paediatric population of six to eight week age group showed it as ‘safe’.
“We are pleased to announce that our Phase-III clinical trial results for Pneubevax14 have been published by the Vaccine Journal. We have reached a significant milestone in our ongoing fight against pneumococcal disease and we are now one step closer to the finish line with our Pneubevax14”, Mahima Datla, Managing Director, Biological E said in a release.
In this study, the immunogenicity and safety of the BE-PCV-14 containing two additional epidemiologically important serotypes (22F and 33F) were evaluated in infants, in comparison to the licensed comparator vaccine PCV-13.
This was a pivotal Phase-III single blind randomised active-controlled study conducted at 12 sites across India in 1,290 healthy infants at 6-10-14 weeks dosing schedule to assess immunogenic non-inferiority and safety of Pneubevax14.
“Pneubevax14 was found to be safe and induced robust and functional serotype specific immune responses to all 14 serotypes. It also elicited cross-protective immune response against serotype 6A. These findings suggest that Pneubevax14 can be safely administered to infants and achieve protection against pneumococcal disease caused by serotypes covered in the vaccine”, says, the company.