drugset / Trial / NCT04772534

Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

NCT04772534

Phase 3 Completed 314 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelPrevention

Summary

The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.

Timeline

Start
2021-05-17
Primary completion
2024-04-06
Completion
2024-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil 9 Vaccine 0.5 ml Intramuscular