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

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
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