A Clinical Study of V540A in Healthy Female Participants (V540A-005)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: V540A-2, V540A-3, GARDASIL®9.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 16 years — 26 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age
Overview
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. 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.
Interventions
- Biological V540A-2
Suspension administered via intramuscular (IM) injection. - Biological V540A-3
Suspension administered via intramuscular (IM) injection. - Biological GARDASIL®9
Suspension administered via IM injection.
Primary outcome measures
- Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE) [Time frame: Up to approximately 7 months]
- Number of Participants Who Experience ≥1 Solicited Pyrexia AE [Time frame: Up to approximately 7 months]
- Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE) [Time frame: Up to approximately 7 months]
- Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3 [Time frame: Up to approximately 7 months]
Secondary outcome measures (6)
- GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 [Time frame: Up to 29 days]
- GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 [Time frame: Up to approximately 3 months]
- GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 [Time frame: Up to approximately 7 months]
- Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 [Time frame: Up to approximately 2 months]
- Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 [Time frame: Up to approximately 3 months]
- Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 [Time frame: Up to approximately 7 months]
Eligibility criteria
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
- Is in good health
- 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
The main exclusion criteria include but are not limited to the following:
- Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07224477 · V540A-005 · U1111-1314-2250 · 2024-518805-16-00