, Volume 27, Issue 5, pp 433-434
Date: 17 Sep 2012

The Author’s Reply

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We thank Cleemput and Thiry[1] for their interest in our research[2] and are grateful for the opportunity to respond.

Since Gardasil® is a prophylactic quadrivalent vaccine that targets four human papillomavirus (HPV) types (6/11/16/18), the per protocol population (PPE) was used as the primary analysis population to evaluate the prophylactic efficacy of Gardasil® on the incidence of diseases caused by vaccine HPV types (PPE: received all three doses of vaccine, naive to the relevant HPV vaccine type at baseline and 1 month after complete vaccination). The measured prophylactic efficacy against cervical intraepithelial neoplasia (CIN)-2/3 related to HPV vaccine types 6/11/16/18 was almost 100% in the PPE population.

The figures reported by Cleemput and Thiry[1] correspond to another population (restricted, modified intent-to-treat-2 population: received at least one dose of vaccine, generally naive to all 14 HPV types tested and with negative Pap test at baseline) used in the clinical tr ...