Gardasil Sicentific Discussion

Study 018

This study was conducted to further define the safety and immunogenicity of the quadrivalent HPV vaccine in 9- to 15-year-old subjects. Study P018 also provided a comparison to non-aluminium-containing placebo. Enrolment was stratified by gender and age (1:1 male/female; 2:1 9-12 year-old/13-15 year-old). The study population contained almost 700 subjects aged 9 to 12 years. Primary objective was to assess safety, but the study also included secondary immunogenicity objectives to demonstrate that the 4-week postdose 3 anti-HPV 6/11/16/18 immune responses (GMTs and percentage of subjects who seroconvert) in pre-/adolescent boys were non-inferior to the responses observed in pre-/adolescent girls All subjects demonstrated a strong antibody response to the HPV vaccine. GMTs at Month 7 were higher among boys than girls. The Month 7 GMTs for all vaccine types were higher among 9- to 12-year-old subjects than among 13- to 15-year-old subjects. The statistical criteria for non-inferiority with respect to both GMTs and seroconversion rates were met.

抗体価は、９－１２歳の方が、１３－１５歳よりも高かった。

7ヶ月目の抗体価は、男子の方が女子よりも高かった。

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000703/WC500021140.pdf