NCT07785843RecruitingPhase 3
A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108)
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Immunogenicity and Safety of V503 in Chinese Females Aged 10 to 45 Years Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
Researchers want to learn if V503 (also called the 9-valent human papillomavirus \[9vHPV\] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine. The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18). The goals of the trial are to learn: * If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine * About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 930 (estimated)
- First submitted
- 21 Aug 2026
- Start date
- 10 Oct 2026
- Primary completion date
- 18 Dec 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT07785843
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 930
- From 10 Oct 2026 to the primary completion date, 18 Dec 2027
- 1 site 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 received, is receiving, or plans to receive the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies (including rituximab \[Rituxan™\]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if the participant is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
- Has received, is receiving, or plans to receive any immune globulin product (including RhoGAM™ \[Ortho-Clinical Diagnostics\]) or blood derived product other than IVIG.
- Has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
- Has received any marketed HPV vaccine other than the 2vHPV vaccines.
Other illness
- Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Has a history of abnormal Pap test showing low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells - undetermined significance (ASC-US), atypical squamous cells - cannot exclude HSIL (ASC-H), atypical glandular cells, or biopsy showing CIN, AIS, or cervical cancer.
- Has a history of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), AIN, vulvar cancer, vaginal cancer, or anal cancer.
- Has a history of a positive test for HPV (including HPV types not in the vaccine).
- Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
- Has a history of splenectomy.
Other
- The main exclusion criteria include but are not limited to the following:
Who the study is looking for
- The main inclusion criteria include but are not limited to the following:
- For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus \[HPV\] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1.
- For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.
Age in the registry: 10 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yuhuan Center for Disease Control and Prevention ( Site 0001) Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.