Merck’s investigational 15-valet conjugate vaccine for the prevention of invasive pneumococcal disease (IPD) in children has been granted Breakthrough Therapy Designation in the US.
V114 is also under development for the prevention of IPD 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, multicentre, 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.
Nicholas Kartsonis, Senior Vice President and Head of Vaccine and Infectious Diseases Clinical Research at Merck Research Laboratories, said: “The goal of our program in paediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”