Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05450705
Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Has a history of known prior vaccination with an HPV vaccine.
* 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 received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
* 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.
* Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
9 Years
Maximum Age:
26 Years
Study:
NCT05450705
Study Brief:
Protocol Section:
NCT05450705