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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01691820
Eligibility Criteria:
Inclusion Criteria:
* A female adolescent between, and including 10 and 17 years at the time of enrolment regardless of pregnancy status and contraception method used or not used.
* Subjects who the investigator believes that the subject and/or the subject's parent(s)/Legally Acceptable Representative(s) (LAR\[s\]) can and will comply with the requirements of the protocol.
* Written informed assent and/or consent obtained from the subject and/or the parent(s)/LAR(s) of the subject.
* Subject is likely to remain in the area and/or return for required study Site Visits and complete Sample Collection Visits.
Exclusion Criteria:
* Child in care.
* Use or planned use of any investigational or non-registered antiviral drug or vaccine during the study period.
* Known medical history of any recurrent clinical herpes episodes requiring episodic or chronic suppressive treatment with oral or parenteral antiviral treatment such as acyclovir, famciclovir, valacyclovir or any other anti-herpes virus anti-viral during the year preceding enrolment. Topical anti-viral are allowed.
* Subjects with history of previous vaccination against CMV.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to Visit 1 or planned administration during the study. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products within 3 months prior to Visit 1 or planned administration during the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including HIV-infection, based on medical history and physical examination (no laboratory testing required).
* Any major congenital defects, serious chronic illness or organ transplantation.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01691820
Study Brief:
Protocol Section:
NCT01691820