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Gardasil Demonstrates Up to 100% Efficacy

e incidence of pre-cancerous and potentially pre-cancerous cervical lesions (CIN 1-3), pre-cancerous and potentially pre-cancerous vulvar and vaginal lesions (VIN1-3 and VaIN1-3) and external genital warts caused by the Human Papillomavirus types 6, 11, 16 and 18. FUTURE II evaluated the prevention of pre-cancerous cervical lesions (CIN 2/3) and non-invasive cancers (AIS) caused by Human Papillomavirus types 16 and 18.
c) 20,541 women (16-26 years) from the Americas, Europe and Asia were enrolled in one of four trials. In one trial, subjects were randomised to either a monovalent Human Papillomavirus 16 vaccine or placebo. In 3 trials, subjects were randomised to either Gardasil® (types 6/11/16/18) or placebo. For all trials, vaccination occurred at day 1, and months 2 and 6. The primary endpoint was the combined incidence of Human Papillomavirus types 16/18-related CIN 2/3, AIS, or cervical cancer. In the Human Papillomavirus 16 vaccine study, only Human Papillomavirus 16-related cases were considered. Analyses were done in a per protocol (PP) population (subjects received 3 doses, had no major protocol violations, were Human Papillomavirus 16/18 seronegative at day 1 and Human Papillomavirus 16/18 DNA negative Day 1 through month 7). Endpoint counts began at Month 7.
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