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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01489527
Eligibility Criteria:
Inclusion Criteria:
* Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
* HIV negative
* has ever had vaginal intercourse
* has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
* fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
* agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
* agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
* agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
* Informed consent procedures for females \<18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.
Exclusion Criteria:
* have a history of severe allergic reaction
* have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
* are currently immuno-compromised
* have received a marketed HPV vaccine, or are pregnant and lactating
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT01489527
Study Brief:
Protocol Section:
NCT01489527