FDA to review pediatric hexavalent vaccine

The FDA has accepted for review a Biologics License Application filed by Merck and Sanofi Pasteur for a pediatric hexavalent combination vaccine containing DTaP, inactivated poliovirus, Haemophilus influenzae type B and hepatitis B vaccines, according to a company press release.

The application acceptance is based on phase 3 study data, presented at IDWeek 2014 in Philadelphia, which indicated vaccine safety and immunogenicity among infants.

Study researcher Gary S. Marshall, MD, of the Louisville School of Medicine in Louisville, Ky., and colleagues randomly assigned more than 1,400 healthy infants to the hexavalent vaccine or Pentacel (Sanofi Pasteur) plus Recombivax HB (Merck) at ages 2, 4 and 6 months.

After the third infant dose, analysis indicated antibody levels among those who received the investigational vaccine were non-inferior to those who received Pentacel plus Recombivax HB for nearly all but one pertussis comparison. Antibody levels were compared again after study participants received the toddler dose of Pentacel plus Recombivax HB. This second analysis indicated antibody levels among those who received the hexavalent vaccine were non-inferior to antibody levels among those who received Pentacel plus Recombivax for all pertussis comparisons.

Irritability, crying and drowsiness were the most common adverse events following any dose of the hexavalent vaccine.

“We are encouraged by the results of this phase 3 trial,” Marshall said in a press release. “This investigational combination vaccine against six important diseases showed similar immune responses against antigens covered by licensed vaccines.”

The hexavalent vaccine contains DTaP and poliovirus antigens from Sanofi Pasteur and Haemophilus influenzae type B and hepatitis B antigens from Merck.