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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT04235257
Eligibility Criteria:
Inclusion Criteria:
* Age 27-45 years at enrollment
* Not intending to receive the HPV vaccine series for the duration of the study participation
* Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule
Exclusion Criteria:
* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
* Currently pregnant or breastfeeding
* Immune deficiency or other immune disorder
* HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
* Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
* Known allergy to vaccine components
* Prior history of HPV-associated cancer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
27 Years
Maximum Age:
45 Years
Study:
NCT04235257
Study Brief:
Protocol Section:
NCT04235257