A Clinical Study of V540A in Healthy Female Participants (V540A-005)
NCT ID: NCT07224477
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
525 participants
INTERVENTIONAL
2026-07-20
2028-04-04
Brief Summary
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A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types.
Researchers want to learn if V540A:
* Is safe and if people tolerate it
* Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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V540A-2
Participants will receive vaccinations of V540A-2.
V540A-2
Suspension administered via intramuscular (IM) injection.
V540A-3
Participants will receive vaccinations of V540A-3.
V540A-3
Suspension administered via intramuscular (IM) injection.
GARDASIL®9
Participants will receive vaccinations of V503.
GARDASIL®9
Suspension administered via IM injection.
Interventions
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V540A-2
Suspension administered via intramuscular (IM) injection.
V540A-3
Suspension administered via intramuscular (IM) injection.
GARDASIL®9
Suspension administered via IM injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a lifetime history of 0 to 4 sexual partners of any sex/gender
* A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention
Exclusion Criteria
* Has known or history of functional or anatomic asplenia
* Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
* Has thrombocytopenia or other coagulation disorder
* Has had a positive test for human papillomavirus (HPV)
* Has a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
* Has a history of an abnormal cervical biopsy result
* Has a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
* Has received a dose of any HPV vaccine before study entry
* Has received within 12 months before the Day 1 vaccination, is receiving, or plans to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
* Is currently receiving systemic steroid therapy or has received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
* Has received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product
16 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1314-2250
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-518805-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
V540A-005
Identifier Type: -
Identifier Source: org_study_id