Posted by Michael Wonder on 30 Jan 2019
Merck receives breakthrough therapy designation from FDA for V114, the company’s investigational 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease, in infants, children, and adolescents
30 January 2019 - Merck today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. FDA for the prevention of invasive pneumococcal disease caused by the vaccine serotypes in paediatric patients 6 weeks to 18 years of age.
V114 is also under development for the prevention of invasive pneumoccoccal disease in adults. Both indications are currently being studied in Phase 3 clinical trials.
The FDA’s decision was informed in part by immunogenicity data from two studies. Study 005 was a Phase 1/2, multi-centre, randomised, double-blind study to evaluate the safety, tolerability and immunogenicity profiles of 4 different lots of a new formulation of V114 in healthy adults and infants. Study 008 was a proof of concept, Phase 2, paediatric trial to confirm the results from Study 005 in a larger population of infants. In both studies, V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines.
