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Phase 3 randomized placebo-controlled study of 9-valent HPV vaccine in Japanese males 16–26 years
jRCT2031200217Phase 3Completed
- Sponsor
- Merck & Co.
- Start
- Nov 2020
- 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
01
Overview
Phase 3, randomised, double-blind trial in human papillomavirus infection and genital human papillomavirus infection (HPV) comparing 9vHPV vaccine (Gardasil 9) with Placebo (saline) (2 arms). Primary endpoints: Combined incidence of HPV 6/11/16/18-related anogenital persistent infection, Percentage of participants with solicited injection-site adverse events and 2 more. Started Nov 2020; status: completed.
02
Drugs
recombinant human papillomavirus 9-valent vaccine
03
Conditions
human papillomavirus infectiongenital human papillomavirus infection (HPV)
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