Merck and Sanofi To Conduct Phase III Pediatric Vaccine Study


This per a pharmaceutical trade magazine’s online aggregator:

. . . .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. . . .

We’ll keep you posted — when outcomes data are made availbale.

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