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GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets,Phase II Study Endpoints of Immunogenicity and Safety Compared to,Licensed Vaccines

Investigational vaccine could offer protection for infants against Haemophilus influenzae type b and meningococcal disease

TORONTO, Canada, May 11, 2007 — GlaxoSmithKline (GSK) announced results from a Phase II vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The new data suggest that the investigational Hib-MenCY-TT vaccine holds potential to protect infants in the first year of life against invasive disease caused by three strains of bacteria: Neisseria meningitidis serogroups C (MenC) and Y (MenY) and Haemophilus influenzae type b (Hib). The pediatric combination vaccine is currently in Phase III clinical studies and an application for licensure in the United States has not been submitted.

“Infants 12 months of age and younger are at the greatest risk of having meningococcal infections,” said Jacqueline M. Miller, M.D., Director, Clinical Research and Development and Medical Affairs, GlaxoSmithKline Biologicals. “This investigational Hib-MenCY-TT vaccine was designed to be administered at the 2-, 4-, 6-, and 12- or 15-month well child visits. If ultimately approved on this dosing schedule, it would not require the addition of shots to the current CDC-recommended pediatric immunization schedule.”

While the current CDC-recommended vaccination schedule calls for infants to be vaccinated against certain bacteria that cause meningitis such as Haemophilus influenzae type b and Streptococcus pneumoniae in the first year of life, there is currently no vaccine available to protect infants against any serogroup of Neisseria meningitidis.

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