GlaxoSmithKline (GSK) has announced results from a US phase III vaccine clinical study presented at the Paediatric Academic Societies' (PAS) Annual Meeting in Toronto, Canada. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV (diphtheria, tetanus, acellular pertussis - inactivated poliovirus) vaccine in children ages 4 to 6 years-old as compared to separately administered DTaP and IPV vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine at a separate site.
Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines. The investigational DTaP-IPV vaccine has not been approved for use in the United States.
The Centres for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), the American Academy of Paediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that children receive booster shots to protect against diphtheria, tetanus and pertussis (DTaP) and polio (IPV) at the 4 to 6 year-old doctor visit. Most states in the US require either a fifth dose of DTaP vaccine or a fourth dose of IPV vaccine for kindergarten school entry. Separately administered DTaP and IPV vaccines are currently used to complete these recommended immunizations.
"An increasing number of vaccines are being recommended to prevent childhood diseases, including additional vaccines at the 4 to 6 year-old doctor's visit," said Barbara Howe, MD, vice president, North American vaccine development, GlaxoSmithKline. "We are pleased to be developing a new combination vaccine that if approved, could offer one potential solution to the problem of increased number of injections during single doctor visits."