At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 314 enrolled
Drug / intervention
9vHPV vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.
In Brief
A Phase 3 clinical trial evaluating 9vHPV vaccine for Papillomavirus Infections. Completed, enrolled 314 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedFeb 2021
Enrollment StartMay 2021
Primary CompletionApr 2024
TodayJul 2026
First PostedFeb 26, 2021
Enrollment StartMay 17, 2021
Primary CompletionApr 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.4 years ago
Interventions
9vHPV vaccinebiological
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection