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GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix

gnificant disease burden."

In making its recommendation, the FDA Advisory Committee reviewed several clinical trials which included safety and immunogenicity data from one pivotal trial, which studied Boostrix in more than 3,000 adolescents in the United States, aged 10 to 18. The Phase III clinical trial showed Boostrix to be comparable to a U.S.- licensed Td vaccine [Tetanus and Diphtheria Toxoids] with regard to overall safety and immunogenicity. In addition, the use of Boostrix induced anti-pertussis antibody levels, which were statistically higher than those observed in infants following primary immunization with a DTaP vaccine (Infanrix) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed] in whom efficacy against pertussis disease was demonstrated in a previous study.

In this observer-blinded, randomized, controlled, multi-center clinical trial, 4,114 healthy 10-18-year-olds were vaccinated with one dose of Boostrix or a U.S.-licensed Td vaccine. Each subject had completed his or her routine childhood vaccinations against diphtheria, tetanus and pertussis according to the U.S. recommended schedule. According to study results:

  • In both treatment groups, > 99.9 percent of subjects had anti-diphtheria and anti-tetanus concentrations > 0.1 IU/ml, indicating seroprotection against diphtheria and tetanus
  • In the Boostrix treatment group, the levels of anti-pertussis antibodies, anti-PT, anti-FHA and anti-PRN were measured and were statistically higher than pertussis antibody concentrations observed in infants, following primary immunization with a DTaP vaccine (Infanrix), in whom efficacy against pertussis disease was previously demonstrated
  • The overall safety profile was comparable between the Boostrix and Td groups

"Adolescents are an important reservoir for the disease and often the source of infection for infants," noted Dr. Colin Marchant, adjunct associate professor, Boston Un
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Contact: Amanda Foley
919-483-2839
Cohn & Wolfe
15-Mar-2005


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