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NCT05450705

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of a 9vHPV Vaccine (V503) in Chinese Girls 9 Through 14 Years of Age With a Comparison to 3-Dose Regimen of V503 in Chinese Women 20 Through 26 Years of Age
Merck Sharp & Dohme LLC·Phase 3·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
9vHPV vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Quzhou,Taizhou, China
Timeline & enrollment
Phase
Phase 3
Start date
Jul 22, 2022
End date
Aug 03, 2029
Enrollment
1500 participants
Primary outcome

Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine,Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age,Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age

Summary

This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus
 (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay
 (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9
 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of
 age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in
 the GMT ratio (girls vs. women) for each HPV type.

ICD-10 classifications
Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05450705
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05450705 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme LLC and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 1500 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.