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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01634503
Eligibility Criteria:
Inclusion Criteria:
* Female aged between 20 and 50(inclusive).
* Those who promised not to get pregnant from initiation to the first follow-up visit
* Who has diagnosed with Cervical Intraepithelial Neoplasia 3 by histopathologic examination and HPV type 16 or 18 detected
* Those who signed a voluntary written informed consent form for study participation.
Exclusion Criteria:
* Pregnant or lactating women.
* Administration of immunosuppressant or immunomodulator within 6 months prior to the enrollment
* Concomitant medication of any corticosteroid agents within 4 weeks prior to vaccination with the test drug
* Prior immunotherapy against HPV
* Administration of any blood products within 3 months prior to the screening visit
* Administration of any vaccine within 4 weeks prior to the screening visit (ex. Hepatitis A vaccine, Hepatitis B vaccine, Influenza vaccine, Td etc.)
* Positive serum test results for hepatitis C virus, hepatitis B virus surface antigen(HBsAg), or HIV
* Prior participation in any clinical trial within 30 days prior to the screening visit
* Patients predisposed to inflammatory reaction due to use of medical devices such as electroporation within 30 days of screening visit
* Past history of epilepsy or convulsion within 2 years prior to the screening visit
* At the discretion of the investigator, the skin condition covering deltoid muscles, within 2cm of the intended sites of injection, is not suitable for injection due to infection, ulcer, edema, tattoo, scar, injury etc.
* The thickness of skin fold covering deltoid muscles, intended injection sites, \>40mm
* Any orthopedic artificial implant around the intended sites of electroporation (deltoid muscles)
* Any history of severe adverse drug events or severe allergic diseases
* Sinus bradycardia whose resting heart rate \< 50beats/min.
* Pre-excitation syndrome such as Wolff-Parkinson-White syndrome
* Artificial implants or metallic implants
* Abnormal electrocardiography (ECG) including arrhythmia
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01634503
Study Brief:
Protocol Section:
NCT01634503