Merck, Sanofi Pasteur start Phase-3 trials of paediatric combination vaccine in US

Merck & Co and Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, have announced the initiation of a Phase III clinical programme to evaluate the safety and immunogenicity of an investigational paediatric hexavalent combination vaccine.

This combination vaccine is designed to help protect against six potentially serious diseases: diphtheria, tetanus, whooping cough (bordetella pertussis), polio (poliovirus types 1, 2, and 3), invasive disease caused by Haemophilus influenzae type b, and hepatitis B.

The investigational vaccine is a combination of select components: DTaP5-IPV-Hib-HepB; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Outer Membrane Protein Complex), and Hepatitis B (Recombinant) Vaccine. The vaccine is being developed as part of a partnership between Merck and Sanofi Pasteur that focuses on the development of pediatric combination vaccines.

"Combination vaccines simplify the childhood immunisation schedule and may improve coverage, on time vaccination and reduce the number of injections for children," said Gary S Marshall, MD, professor of pediatrics, University of Louisville School of Medicine.

The Phase III clinical programme will begin in the United States with a randomised, open-label, active-comparator controlled clinical trial that will involve approximately 1,440 infants at multiple centers.

The primary study objectives are to assess the safety and immunogenicity of the investigational hexavalent combination vaccine when given at 2, 4, and 6 months of age concomitantly with Prevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent). The clinical program is expected to begin in Europe this year. For more information on this study, please visit www.clinicaltrials.gov.