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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.

About the Hib-MenC Y-TT Vaccine Study

The Phase II study evaluated the immune response and safety of Hib-MenCY-TT compared to a licensed monovalent Hib conjugate vaccine (ActHib® Haemophilus influenza type b Conjugate Vaccine Tetanus Toxoid Conjugate) in infants and to a licensed polysaccharide meningococcal ACWY vaccine (Menomune® Meningococcal Polysaccharide Vaccine, Serogroups A, C, Y and W-135 Combined) in children 3-5 years of age.

In this single-blind, Phase II study, 609 infants were randomized 1:1 to receive either Hib-MenCY-TT or licensed Hib vaccine at 2, 4, and 6 months concomitantly with DTaP-Hep B-IPV (Pediarix®Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined) and pneumococcal 7-valent conjugate vaccine (Prevnar® Pneumococcal 7-valent Conjugate Vaccine Diphtheria CRM Protein). A second control group of 150 children 3-5 years of age received one dose of Neisseria meningitidis serogroups A, C, W-135 and Y polysaccharide vaccine with no co-administered vaccines. Serologic follow-up was conducted one month after dose 3 of Hib-MenCY-TT/Hib or one month after ACWY, and safety follow-up was conducted from enrollment in the study until 31 days after dose 3 in the Hib-MenCY-TT/Hib groups and 31 days after vaccination in the ACWY group. The primary safety follow-up period of interest was defined as the four days immediately following each vaccination.

Results from the study are:

  • Hib immune response induced by the Hib-MenCY-TT combination vaccine was non-inferior and statistically significantly higher than the monovalent Hib vaccine (93.5% anti-PRP ? 1 mcg/mL vs. 85.8% PRP ? 1 mcg/mL, respectively).
  • The Hib-MenCY-TT combination vaccine induced antibodies nea rly two times higher than the monovalent Hib vaccine produced (7.99 mcg/mL vs. 4.39 mcg/mL, respectively).
  • The Hib-MenCY-TT combination vaccine demonstrated an immune response to MenC and MenY in infants that was non-inferior and statistically significantly higher for MenC and non-inferior and comparable for MenY to the immune response induced by ACWY in older children (97.7% of Hib-MenCY-TT had consolidated SBA-MenC response vs. 79.4% of ACWY and 96% of Hib-MenCY-TT had consolidated SBA-MenY response vs. 94.2% of ACWY). The data should be interpreted cautiously given the difference in age of the two treatment groups.
  • Overall grade 3 solicited and unsolicited adverse events (AEs) for the combination Hib-MenCY-TT vaccine were statistically significantly lower than the monovalent Hib vaccine (local AEs were 5.2% in Hib-MenCY-TT vs. 12.9% in Hib and systemic AEs were 8.7% in Hib-MenCY-TT vs. 18.2% in Hib). The most common solicited local AE overall for both the combination Hib-MenCY-TT vaccine and the Hib control groups was pain at the Hib-containing injection site. The most common solicited systemic AE overall for both treatment groups was general irritability.
  • Immunologic interference was not observed when Hib-MenCY-TT was administered with DTaP-Hep B-IPV and pneumococcal 7-valent conjugate vaccine.

About Meningococcal Disease

In the United States each year, there are approximately 2,500 cases of invasive meningococcal disease. Meningitis, an infection caused by Neisseria meningitidis, is a serious and devastating disease with mortality rates of approximately 10% and up to 19% of patients suffering long term effects such as brain damage, amputation, severe skin scarring, kidney damage, mental retardation and deafness. Infants and young children are at the greatest risk for this disease, with approximately 40% of cases occurring in children less than 2 4 months of age. Approximately 50% of meningococcal disease in infants in the United States is caused by serogroups C and Y. The majority of the remaining meningococcal disease is caused by serogroup B, for which there are no licensed vaccines in the United States for any age groups.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world’s children from up to six diseases in one vaccine.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties th at may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the ‘Business Review’ in the company's Annual Report on Form 20-F for 2006.

ActHib® is a registered trademark of sanofi pasteur, the vaccines business of sanofi-aventis Group.

Menomune® is a registered trademark of sanofi pasteur, the vaccines business of sanofi-aventis Group.

Prevnar® is a registered trademark of Wyeth Pharmaceuticals.

Liad Diamond


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