NCT05450705Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 28 Jun 2022
- Start date
- 22 Jul 2022
- Primary completion date
- 3 Aug 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05450705
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1500
- From 22 Jul 2022 to the primary completion date, 3 Aug 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of known prior vaccination with an HPV vaccine.
- 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 received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
Other illness
- 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 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 9 years to 26 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangshan Center for Disease Control and Prevention ( Site 0001) Coordinator of this site? Confirm its status | Quzhou | China | Unknown status |
| Yuhuan Center for Disease Control and Prevention ( Site 0002) Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.