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 @ 4:22 AM
Ignite Modification Date:
2025-12-25 @ 4:22 AM
NCT ID:
NCT00090220
Eligibility Criteria:
Inclusion Criteria:
* No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
* Not pregnant and agrees to use effective contraception through Month 7 of the study
* Additional criteria applied
Exclusion Criteria:
* Pregnant
* Concurrently enrolled in a clinical study involving collection of cervical specimens
* Previously received any HPV vaccine
* History of severe allergic reaction that required medical intervention
* Received any immune globulin or blood-derived products within 3 months prior to the first study injection
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection
* Known thrombocytopenia or any coagulation disorders that could contraindicate intramuscular injections
* History of recent or ongoing alcohol or drug abuse
* Prior treatment for genital warts, VIN, or VaIN
* History of cervical disease (ie, surgical treatment for cervical lesions)
* Hysterectomy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
24 Years
Maximum Age:
45 Years
Study:
NCT00090220
Study Brief:
Protocol Section:
NCT00090220