Spots Global Cancer Trial Database for Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
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Trial Identification
Brief Title: Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
Official Title: An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)
Study ID: NCT03158220
Interventions
Study Description
Brief Summary: This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.
Detailed Description:
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 0002), Graz, , Austria
Klin. Abtlg. fuer Gynaekologie und Geburtshilfe ( Site 0001), Wien, , Austria
Universitair Ziekenhuis Antwerpen ( Site 0007), Edegem, , Belgium
Universitair Ziekenhuis Gent ( Site 0006), Gent, , Belgium
Universitair Ziekenhuis Gasthuisberg ( Site 0005), Leuven, , Belgium
University of Antwerp ( Site 0004), Wilrijk, , Belgium
HUS Katiloopiston sairaala ( Site 0009), Helsinki, , Finland
Ita-Helsingin Rokotetutkimuskeskus ( Site 0011), Helsinki, , Finland
Porin Rokotetutkimusklinikka ( Site 0012), Pori, , Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0010), Tampere, , Finland
Turun rokotetutkimusklinikka ( Site 0037), Turku, , Finland
Universitaetsmedizin Berlin Charite ( Site 0016), Berlin, , Germany
Universitaetsklinikum Duesseldorf ( Site 0014), Dusseldorf, , Germany
Praxis Dr. Peters ( Site 0015), Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0017), Hamburg, , Germany
Universitaetsklinikum Tuebingen ( Site 0013), Tuebingen, , Germany
Istituto Nazionale dei tumori ( Site 0020), Milano, Milan, Italy
Ospedale San Raffaele ( Site 0022), Milano, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0023), Palermo, , Italy
CAP Centelles ( Site 0027), Centelles, Barcelona, Spain
Complejo Hospitalario de Torrecardenas ( Site 0030), Almeria, , Spain
Institut Catala Oncologia de Bellvitge - ICO ( Site 0026), Hospitalet de Llobregat, , Spain
Hospital Sanitas La Moraleja ( Site 0031), Madrid, , Spain
Hospital Universitario Infanta Leonor ( Site 0028), Madrid, , Spain
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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