Study design & results
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Trial intelligence / Profile preview
BioHPV
2024-520140-42-00Phase 3Authorised
- Sponsor
- Gustave Roussy
- Start
- Jan 2026
- 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 Squamous Intraepithelial Lesion (SIL), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN) and 4 more comparing Gardasil 9 with Placebo (2 arms). Primary endpoint: Time to HPV type-specific recurrence of HSIL at the initial site. Planned start Jan 2026; status: authorised.
02
Drugs
recombinant human papillomavirus 9-valent vaccine
03
Conditions
Squamous Intraepithelial Lesion (SIL)vulvar intraepithelial neoplasia (VIN)vaginal intraepithelial neoplasia (VAIN)cervical intraepithelial neoplasia (CIN)anal intraepithelial neoplasia (AIN)
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