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

GARDASIL was assessed in 8915 women (GARDASIL N = 4666; placebo N = 4249) 18 to 26 years of age and female adolescents 9 to 17 years of age (GARDASIL N = 1471; placebo N = 583). Type-specific competitive immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type. These assays measured antibodies against neutralizing epitopes for each HPV type. The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate. Immune Response to GARDASIL The primary immunogenicity analyses were conducted in a per-protocol immunogenicity (PPI) population. This population consisted of individuals who were seronegative and PCR negative to the relevant HPV type(s) at enrollment, remained HPV PCR negative to the relevant HPV type(s) through 1 month Postdose 3 (Month 7), received all 3 vaccinations, and did not deviate from the study protocol in ways that could interfere with the effects of the vaccine. Overall, 99.8%, 99.8%, 99.8%, and 99.5% of girls and women who received GARDASIL became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3 across all age groups tested. Anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 GMTs peaked at Month 7. GMTs declined through Month 24 and then stabilized through Month 36 at levels above baseline (Table 3). The duration of immunity following a complete schedule of immunization with GARDASIL has not been established. Table 3 Summary of Anti-HPV cLIA Geometric Mean Titers in the PPI* Population ---------------------------------------------------------------------- GARDASIL Aluminum-Containing Placebo N** = 276 N = 275 Study Time --------------------------------------------------------- Geometric Mean Titer Geomet
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