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Gardasil / Human papillomavirus / Cervarix / Wart / Cervical cancer / HPV vaccine / Vaginal intraepithelial neoplasia / Genital wart / Vulvar intraepithelial neoplasia / Papillomavirus / Medicine / Microbiology


Clinical Review Memo of BLA Supplement for Human Papillomavirus Vaccine
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File Size: 2,52 MB

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Company

Merck Inc. / GlaxoSmithKline / /

Country

United States / Australia / /

Event

FDA Phase / Product Recall / Product Issues / /

IndustryTerm

prevention of cervical cancer / control / passive surveillance systems / prevention of vaginal and vulvar cancers / Prevention of the following diseases / /

MedicalCondition

related disease / vulvar and vaginal cancer / HPV infection / Genital warts / vulvar and vaginal squamous cell cancers / CIN / respective carcinomas / Adenocarcinoma / Papillomavirus (HPV) infection / cancers / vulvar and vaginal carcinomas / Cancer / Cervical intraepithelial neoplasia grade / disease / prevalent infection / HPV / Cervical Cancer / vaccine and non-vaccine HPV type infection / well-differentiated vulvar cancer / vulvar cancer / Cervical intraepithelial neoplasia / additional cervical and external genital disease / development genital disease / diseases / vulvar and vaginal cancers / infection / vaginal cancer / vaginal and vulvar cancers / ANY HPV infection / /

MedicalTreatment

vaccination / /

Organization

Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration Subject / Food and Drug Administration / Center for Drugs / Vaccines Research and Review Center for Biologics Evaluation / Division of Vaccines / Division of Reproductive and Urologic Products / Related Products Applications office of Vaccines Research / European Union / Vaccines and Related Products Applications office of Vaccines Research / Vaccines and Related Biological Products Advisory Committee / /

Person

Douglas Pratt / Gerald Willett / M. Srodon / Andrea Sutherland / Joseph Toerner / Nancy B. Miller / Elizabeth Valenti Martha Lee / /

Position

investigator / Team Leader / Physician / General Information Product Applicant Pharmacologic Category / updated Physician / Medical Officer / /

Product

sodium chloride / Safety Immunogenicity Human Carcinogenicity / BLA / VLP / BLA supplement / Gardasil® / HPV-015 / Gardasil / HPV-007 / /

Technology

013 Protocol / antibodies / 015 Protocol / 5 Per Protocol / Extension Protocol / Geriatrics / /

URL

http /

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