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New Data Show That GlaxoSmithKline's Rotarix(R) Could Be Given With Other Routine Infant Vaccines in the U.S.
Date:9/19/2007

ines for Virus Diseases, GlaxoSmithKline Biologicals. "If the candidate vaccine is approved, infants could complete the rotavirus vaccine series by four months of age."

The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.

About the Rotarix(R) Co-Administration Study

This Phase III study was conducted to confirm that two doses of the rotavirus candidate vaccine do not impair the immune response to routine infant vaccines currently used in the U.S. In the study, 484 healthy infants ranging from six to 12 weeks of age were randomized (1:1) into two groups. One group received three doses of the currently recommended infant vaccines, Pediarix(R) (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine), Prevnar(R) (Pneumococcal 7-valent Conjugate Vaccine) and ActHIB(R) (Haemophilus b Conjugate Vaccine), at two, four, and six months of age with the rotavirus candidate vaccine co-administered at two and four months of age (n=249). The second group received the rotavirus candidate vaccine administered separately at three and five months of age (n=235) as well as three doses of the currently recommended infant vaccines at two, four and six months of age.

Serum antibodies were measured one month after the third dose of routine vaccines (Pediarix, Prevnar and ActHIB). Antibody responses to routine vaccines were similar in both groups, indicating that the rotavirus candidate vaccine can be co-administered with other routine vaccinations without interfering with the immune response to any of the administered vaccines.

Results from the active phase of this study were included in GSK's Biologics License Application (BLA) for t
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SOURCE GlaxoSmithKline
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