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Merck, Sanofi start pediatric vaccine phase III trial

Merck and Sanofi Pasteur have initiated a Phase III clinical program to evaluate the safety and immunogenicity of an investigational pediatric hexavalent combination vaccine.

The combination vaccine will help protect from six infectious diseases including 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 vaccine is a combination of DTaP5-IPV-Hib- HepB; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate, and Hepatitis B Vaccine.

The Phase III clinical study will begin in the US with a randomized, open-label, active-comparator controlled clinical trial involving about 1,440 infants at multiple sites.

The primary trial objectives are to assess the safety and immunogenicity of the investigational hexavalent combination vaccine when given at 2, 4, and 6 months of age with Prevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) and ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent) while the clinical program is expected to begin in Europe this year.

The company’s Phase IIb clinical trial involved 459 children that assessed the safety and immunogenicity of the investigational combination vaccine.

Merck Vaccines Research senior vice president Tony Ford-Hutchinson said the need to consolidate vaccinations for infants becomes increasingly important as the number of diseases that vaccines help prevent continues to increase.

"The development of a hexavalent combination vaccine is complex. The ability to share expertise and capabilities with our partner Sanofi Pasteur is fundamental in reaching our shared goal of developing new combination vaccines that may improve vaccination rates of children," Ford-Hutchinson said.