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Extended 2-dose Regimens of 9vHPV (Gardasil 9) in 9–14 Year Olds vs Standard 3-dose in Young Women

2022-500256-37-00Phase 3Authorised

Sponsor
Merck & Co.
Start
Sep 2022
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Protein Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
6
01

Overview

Phase 3, open-label trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection (6 arms), sponsored by Merck & Co. Primary endpoints: Geometric Mean Titers of anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 weeks post last vaccination, Percentage of participants with at least 1 solicited injection-site adverse event and 2 more. Planned start Sep 2022; status: authorised.

02

Drugs

recombinant human papillomavirus 9-valent vaccine
03

Conditions

human papillomavirus infection

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