US FDA Accepts For Review A Biologics License Application For Merck And Sanofi Pasteur's Investigational Pediatric Hexavalent Vaccine

Merck

, known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi

, announced today that the Biologics License Application (BLA) filed for the companies' investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA). If approved, it would be the first pediatric combination vaccine in the United States designed to help protect against six important diseases – diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b (Hib), and hepatitis B. “We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases,” said Robin Isaacs, M.D., Vice President, Vaccine Clinical Research, Merck Vaccines. “Leading organizations – the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians – generally recommend the use of combination vaccines instead of individual injections,” said John Shiver, Ph.D., Senior Vice President, Research and Development, Sanofi Pasteur. Phase III Clinical Study Data Presented at IDWeek Data from a Phase III study for the investigational pediatric hexavalent vaccine were recently presented at IDWeek in Philadelphia. This Phase III study, a randomized, open-label, active-comparator controlled clinical trial with more than 1,400 infants at multiple centers across the United States, evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines. The investigational and comparator vaccines were given at two, four, and six months of age. In the study, 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). Antibody levels after the third infant doses were measured, and from these measurements 19 primary comparisons between Groups 1 and 2 were evaluated. For 18 of these 19 comparisons (all but one pertussis comparison), the antibodies in the Group 1 infants were non-inferior to those in the Group 2 infants. After the toddler dose of licensed vaccines, antibodies were again measured; the Group 1 antibodies were non-inferior to those in Group 2 for all 8 pertussis comparisons. The most common, solicited, systemic adverse events following any dose of the investigational hexavalent vaccine were irritability (83%), crying (75%), and drowsiness (74%). Solicited systemic adverse event rates after any dose were similar following administration of the investigational pediatric hexavalent vaccine versus control with the exception of increased rates of fever, which was mostly mild to moderate in intensity and two days or fewer in duration. “We are encouraged by the results of this Phase III trial,” said Gary S. Marshall, M.D., professor of pediatrics, University of Louisville School of Medicine, and lead investigator of the study. “This investigational combination vaccine against six important diseases showed similar immune responses against the antigens covered by licensed vaccines.” The partnership between Merck and Sanofi Pasteur draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines. This pediatric hexavalent vaccine includes antigens for diphtheria, tetanus, pertussis (whooping cough), and polio (poliovirus types 1, 2, and 3) from Sanofi Pasteur and antigens for Haemophilus influenzae type b and hepatitis B from Merck.