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Phase 3 randomized double-blind trial of 9-valent HPV vaccine versus Gardasil in men aged 16 to 26 years

2013-003399-10Phase 3Completed

Sponsor
Sanofi Pasteur MSD S.N.C.
Start
Dec 2013
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Protein Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 3, randomised, double-blind trial of recombinant human papillomavirus 9-valent vaccine and qHPV vaccine in human papillomavirus infection, anogenital warts, Cervical Cancer (CC) and 3 more (2 arms), sponsored by Sanofi Pasteur MSD S.N.C. Primary endpoint: cLIA geometric mean titres to HPV 6, 11, 16, and 18. Started Dec 2013; status: completed.

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Drugs

recombinant human papillomavirus 9-valent vaccineqHPV vaccine
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Conditions

human papillomavirus infectionanogenital wartsCervical Cancer (CC)vulvar intraepithelial neoplasia (VIN)vaginal intraepithelial neoplasia (VAIN)

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