A Clinical Study of V540A in Healthy Female Participants (V540A-005)
NCT ID: NCT07224477
Last Updated: 2026-02-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
525 participants
INTERVENTIONAL
2026-07-20
2028-04-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).
NCT06623409
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
NCT00543543
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
NCT00520598
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
NCT01047345
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
NCT00090220
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Plain Language Summary Link
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
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
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.