HPV vaccination in women aged 24-45 years.

摘要

Nubia Munoz and colleagues (June 6, p 1949) report that the quadrivalent human papillomavirus (HPV) vaccine is efficacious in women aged 24-45 years who are not infected with the relevant HPV types. Their study raises several questions. First, the choice of the per-protocol population for the primary analyses of efficacy is understandable if the target population consists of young girls before sexual debut. However, for a woman aged 24-45 years faced with the choice of having the vaccine or not, only the results of the intention-to-treat population are relevant because she does not know then whether or not she resembles the per-protocol population, which is defined on the basis of data acquired after immunisation. For the second coprimary endpoint (infection or disease related to HPV 16 and 18) the observed difference in the intention-to-treat population does not reach significance.