Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066) - Trial NCT04772534
Access comprehensive clinical trial information for NCT04772534 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme Corp. and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
May 17, 2021
Apr 26, 2024
Primary Outcome
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58,Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event,Percentage of Participants With at Least 1 Systemic Adverse Event,Percentage of Participants With at Least 1 Serious Adverse Event,Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event
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 9vHPV vaccine. No hypothesis will be tested since this
 study is an estimation-only study.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04772534
Non-Device Trial