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Randomised controlled trial
The quadrivalent HPV vaccine is effective prophylaxis against HPV-related external genital lesions in young men
  1. Basil Donovan1,
  2. Andrew E Grulich1
  1. 1Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia
  1. Correspondence to Basil Donovan
    Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia;bdonovan{at}

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Awareness is growing that in developed countries around a quarter of human papillomavirus (HPV) related cancers occur in men and that the incidence of some of those cancers, particularly anal cancers1 and certain oropharyngeal cancers,2 is growing. As well as providing direct protection for males, a population-based programme of male HPV vaccination could provide protection for females where the levels of population coverage of female vaccination programmes are limited. There has been no formal evaluation of the efficacy of the HPV vaccination against HPV-related disease in males.


This rigorous randomised, placebo-controlled, double-blind study enrolled 4065 boys and men aged 16–26 years through 71 sites in 18 countries. None was permitted to have had more than five sexual partners in their lives, and boys and men who reported male partners (with or without female partners) were deliberately over-recruited (n=602). Recruitment was between 2004 and 2008, and the median follow-up was 2.9 years. The …

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