Trial intelligence / Profile preview

HOPE 9 Study of presurgical Gardasil 9 to reduce recurrence after LEEP for high-grade cervical neoplasia

2018-003507-19Phase 3Active

Sponsor
Azienda USL Toscana Nord Ovest
Start
May 2021
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 in cervical intraepithelial neoplasia (CIN), Cervical Cancer (CC) and human papillomavirus infection comparing Gardasil 9 presurgical vaccination with Placebo presurgical control (2 arms). Primary endpoint: Reduction in disease recurrence. Started May 2021; status: active.

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Drugs

recombinant human papillomavirus 9-valent vaccine
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Conditions

cervical intraepithelial neoplasia (CIN)Cervical Cancer (CC)human papillomavirus infection

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