| Open Document File Size: 931,28 KBShare Result on FacebookCompany EGL / AEs / Vaccination Group / Non-Concomitant Group / Luminex / Safety Subgroup / Administration Merck Sharp & Dohme Corp. / Merck Sharp & Dohme Corporation / D. / / Country United States / / Event FDA Phase / / IndustryTerm prevention of the following diseases / / MedicalCondition anal cancer / HIV / Disease / headache / HPV / Cervical Cancer / Vulvar Cancer / allergy / Cervical intraepithelial neoplasia / Genital warts / anal cancers / Persistent infection / diseases / CIN / Vaginal Cancer / tonsillitis / vaccine / asthmatic crisis / spontaneous abortion / intraepithelial neoplasia Adenocarcinoma / invasive cervical carcinoma / / MedicalTreatment vaccination / / Organization Food and Drug Administration / Date PDUFA Goal Date Division / FDA / / Person Tsai-Lien Lin / Lot-Consistency Comparisons / Estelle Russek-Cohen / A. Dale Horne / Lot Consistency / AIN AIS ANCOVA ANOVA ANSS / Lihan Yan / Alum Adjuvant / Priority Review Reviewer / Immunobridging Consistency / Laura Montague / Bharat Khurana / / Position Team Leader / Project Manager / Director / DB Applicant / P.H. Chief / Ph. Team Leader / / Product Weeks Post Injection / post / This vaccine / Subjects Who Received qHPV Vaccine / Quadrivalent Human Papillomavirus vaccine / GARDASIL® / Adacel™ Concomitant / Page / GARDASIL / qHPV vaccine / / PublishedMedium the Statistical Review / / Technology Low-Grade Squamous Intraepithelial Lesion Papanicolaou Pseudovirion-based neutralization assay Polymerase Chain Reaction Per Protocol Efficacy Per Protocol / /
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Statistical Review - GARDASIL 9