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AAP Grand Rounds 18:16-17 (2007) How Effective Is the Quadrivalent HPV Vaccine at Preventing High-grade Cervical Lesions?Source: The FUTURE II Study Group Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356:1915–1927; doi:10.1056/NEJMoa061741
Human papillomaviruses (HPV) cause virtually all cervical cancers, with HPV types 16 and 18 responsible for the majority of cases.1 HPV types 6 and 11 cause the majority of anogenital warts.2 A quadrivalent HPV vaccine against HPV types 6/11/16/18 was approved by the FDA in June 2006. Researchers from 13 countries conducted a study to assess the efficacy of HPV vaccine in preventing cervical intraepithelial neoplasia (CIN) grade 2 or 3, adenocarcinoma in situ, and cervical cancer caused by HPV-16 or HPV-18.
Over a one-year period, 12,167 women between the ages of 15 and 26 were enrolled in this double-blind, placebo-controlled, randomized trial. Women were eligible for participation in the study if they were not pregnant, had no history of an abnormal Papanicolaou smear, and reported having had no more than four sex partners. Participants were randomly assigned to receive vaccine or placebo at day 1, month 2, and month 6.
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