Trial intelligence / Profile preview

VulVaccin: Adjuvant nonavalent HPV vaccination in women treated for vulvar HSIL

2023-506792-94-00Phase 4Authorised

Sponsor
Erasmus MC
Start
Jan 2024
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 4, randomised, double-blind trial in HPV-related vulvar intraepithelial neoplasia comparing Gardasil 9 adjuvant vaccination with Placebo (0.9% sodium chloride) (2 arms). Primary endpoint: Clinical recurrence rate of vulvar HSIL at 24 months. Planned start Jan 2024; status: authorised.

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Drugs

recombinant human papillomavirus 9-valent vaccine
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Conditions

HPV-related vulvar intraepithelial neoplasia

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