Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 4:30 AM
Study NCT ID:
NCT04772534
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: