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:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT06142461
Eligibility Criteria:
Inclusion Criteria:
* Female between the age of 12 years and 13 years, inclusive. (Female 7th grade junior high school students in Indonesia)
* Clinically healthy, as established by medical history and physical examination before entering the study.
* Not pregnant at the time of vaccination.
* Able to provide informed consent and assent.
* Able to comply with the study.
Exclusion Criteria:
* Previous vaccination against HPV.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period.
* Administration of any vaccine within 30 days prior the study enrollment, or within 30 days of study vaccination visits.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period.
* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
* History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast.
* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted.
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
* Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period.
* Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature \<37.5°C.
* Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
13 Years
Study:
NCT06142461
Study Brief:
Protocol Section:
NCT06142461