FDA accepts to review Merck and Sanofi Pasteur’s BLA for pediatric hexavalent vaccine

If approved, it would be the first pediatric combination vaccine in the US designed to help protect against six important diseases including diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B.

Merck Vaccines vice-president of Vaccine Clinical Research Robin Isaacs said: "We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases."

The BLA is based on data from a randomized, open-label, active-comparator controlled Phase III clinical trial for the investigational pediatric hexavalent vaccine.

More than 1,400 infants at multiple centers across the US were enrolled in the trial, which evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines.

The company said that the investigational and comparator vaccines were given at two, four, and six months of age.

In the trial, healthy infants were randomized in a 2:1 ratio to receive either the investigational pediatric hexavalent vaccine (Group 1) or Sanofi Pasteur’s Pentacel 2 plus Merck’s Recombivax HB 3 (Group 2).

University of Louisville School of Medicine professor of pediatrics and lead investigator of the trial Gary Marshall said: "This investigational combination vaccine against six important diseases showed similar immune responses against the antigens covered by licensed vaccines."