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

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
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