Investigators have started a Phase III study in the U.S. of a hexavalent pediatric vaccine created by Merck and Sanofi Pasteur. The vaccine is designed to protect against diphtheria, tetanus, whooping cough, polio, hepatitis B and Haemophilus influenzae type b.
The study will monitor the safety and immunogenicity of the vaccine, with 1,440 infants enrolled at multiple centers across the country. It will be administered to the children at 2, 4 and 6 months of age and compared to those receiving Prevnar 13 and Rotateq. Positive results from a Phase IIb trial led to the start of this larger trial.
"The need to consolidate vaccinations for infants will become increasingly important as the number of diseases that vaccines help prevent continues to increase," said Tony Ford-Hutchinson, senior VP, Vaccines Research, Merck, in the joint release. "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."
The vaccine will enter another trial in Europe later this year, according to the release.
- read the Sanofi/Merck release