Pneubevax safe and immunogenic in infants, says Biological E Limited
Hyderabad: Hyderabad-based vaccine and pharmaceutical company Biological E Limited (BE) Tuesday announced the publication of Phase-III clinical trials results of its 14-valent pneumococcal conjugate vaccine (PCV) Pneubevax14 conducted in paediatric population (6-8-week age group). The study results have been accepted and published byVaccine, a peer-reviewed international journal.
This was a 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 Pneubevax. It was found to be safe and induced robust and functional serotype specific immune responses to all 14 serotypes. The findings suggest that Pneubevax can be safely administered to infants and achieve protection against pneumococcal disease caused by serotypes covered in the vaccine.
The safety profile of Pneubevax was comparable to that of the PCV-13 vaccine. The majority of reported adverse events (AEs) were mild in nature.
“We are pleased to announce that our Phase-III clinical trial results for Pneubevax 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 14-Valent PCV vaccine. These findings underscore the success of our R&D and serve as a source of motivation,’’ said Mahima Datla, managing director, Biological E Limited.
