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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02750202
Eligibility Criteria:
Inclusion Criteria:
* Female patient \> 16 years
* Presence of vulvo vaginal genital warts: largest tumour diameter \> 3 cm OR Tumour on labia minora and labia majora OR bilateral \> 1 cm each side OR Tumour in vagina/cervix as well as on vulva \> 1 cm lesion each
* HIV negative or HIV infected and CD4 ≥ 300 cells/mm3 OR viral load controlled OR anti retro-viral (ARV) compliant \> 6 months
Exclusion Criteria:
* Pregnant of planned pregnancy within 6 months
* Not able to comprehend study method or not able to attend all study visits
* Previous HPV vaccination
* Active known opportunistic infection or malignancy including Pneumocystis pneumonia (PCP),Pulmonary tuberculosis (PTB), oesophageal Candida or Kaposi sarcoma or lymphoma
* Known allergy to vaccines or content of vaccine
* Previous radiation for genital warts
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT02750202
Study Brief:
Protocol Section:
NCT02750202