Clinical Trials in China / NCT05450705
Active, not recruiting
Phase 3
V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)
NCT05450705 · tracked via the Priya Life Science China tracker
Condition(s) studied
Papillomavirus Infections
Investigational drug(s) / intervention(s)
9vHPV vaccine: A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection.
Study 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.
Eligibility
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Is a healthy Chinese female.
* Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception during Day 1 through 1 month post last dose.
Exclusion Criteria:
* Has a history of known prior vaccination with an HPV vaccine.
* Has a history of severe allergic reaction that required medical intervention.
* Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
* Has a history of abnormal Pap test or external genital wart, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, anal intraepithelial neoplasia, vulvar cancer, vaginal cancer, or anal cancer.
* Has a history of a positive test for HPV.
* Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
* Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
Primary outcome measure(s)
- Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine — One month after last dose (Up to Month 13)
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL. - Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age — Up to Month 84
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. - Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age — Up to Month 84
cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Jiangshan Center for Disease Control and Prevention ( Site 0001) | Quzhou | Zhejiang | |
| Yuhuan Center for Disease Control and Prevention ( Site 0002) | Taizhou | Zhejiang |
More Merck Sharp & Dohme LLC trials in China
A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
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Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
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Other trials for the same condition
Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)
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Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05450705 on ClinicalTrials.gov ↗ ← All trials in China