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New England Journal of Medicine Publishes New Data on Gardasil,,Merck's Cervical Cancer Vaccine

cents and 16- to 26-year-old Adult Women ---------------------------------------------------------------------- 9- to 15-year-old 16- to 26-year-old Female Adolescents Adult Women (Protocols 016 and 018) (Protocols 013 and 015) Assay N = 1121 N = 4229 (cLIA) -------------------------------------------------------- n GMT (95% CI) n GMT (95% CI) ====================================================================== Anti-HPV 6 915 928.7 (874.0, 986.8) 2631 542.6 (526.2, 559.6) ---------------------------------------------------------------------- Anti-HPV 11 915 1303.0 (1223.1, 1388.0) 2655 761.5 (735.3, 788.6) ---------------------------------------------------------------------- Anti-HPV 16 913 4909.2 (4547.6, 5299.5) 2570 2293.9 (2185.0, 2408.2) ---------------------------------------------------------------------- Anti-HPV 18 920 1039.8 (964.9, 1120.4) 2796 461.6 (444.0, 480.0) ---------------------------------------------------------------------- Note: GMT = Geometric mean titer in mMU/mL (mMU = milli-Merck units). ---------------------------------------------------------------------- Anti-HPV responses 1 month Postdose 3 among 9- to 15-year-old girls were non-inferior to anti-HPV responses in 16- to 26-year-old adolescent and young adult women in the combined database of immunogenicity studies for GARDASIL. On the basis of this immunogenicity bridging, the efficacy of GARDASIL in 9- to 15-year-old girls is inferred. Studies with Other Vaccines The safety and immunogenicity of co-administration of GARDASIL with hepatitis B vaccine (recombinant) (same visit, injections at separate sites) were evaluated in a randomized study of 1871 women aged 16 to 24 years at enrollment. Immune response to both hepatitis B vaccine (recombinan
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