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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02733068
Eligibility Criteria:
Inclusion Criteria:
* 18-30 healthy female
* enable to provide an legal identification
* have the ability to understand and sign the Informed Consent Form
* confirmed by the investigator that the participant has the ability to comply with the protocol requirements
* agreed to use effective contraceptive method in 7 months or has no plan of pregnancy
* can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection
Exclusion Criteria:
* has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection
* within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine
* has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine
* has a history of epilepsy, convulsion or has a family history of mental diseases
* has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease
* used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months
* asplenia, functional asplenia, or splenectomize
* liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor
* coagulation disorders
* in menstrual period or acute diseases
* pregnant, or less than 8 weeks after delivery
* has a history of sexual transmitted disease
* had total hysterectomy or pelvic radiotherapy
* has cervical abnormalities
* abnormal screening results for cervical cancer or had CIN in two years
* according to the judgement of investigator, participant has conditions that were not suitable for this trial
* planning to move out of the clinical trial site during the research period
* never has vaginal sexual activity
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT02733068
Study Brief:
Protocol Section:
NCT02733068