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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT01290393
Eligibility Criteria:
Inclusion Criteria:
For Exposed vaccinated cohort:
* Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Aged between, and including, 15 and 25 years of age.
* Residing within the US or Canada.
* Subjects who received at least one dose of CERVARIX.
* Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
* Last menstrual period between 30 days before and 90 days after any dose of CERVARIX with a maximum of 20% of subjects with last menstrual period between 46 and 90 days after any dose of CERVARIX.
* Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
For Non-exposed vaccinated cohort:
* Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Aged between, and including, 15 and 25 years of age.
* Residing within the US or Canada.
* Subjects who received at least one dose of CERVARIX or at least one dose of GARDASIL.
* Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
* Last menstrual period between 120 days and 18 months after the last dose of CERVARIX/ GARDASIL.
* Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
Exclusion Criteria:
For Exposed vaccinated cohort:
* Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
* Ongoing pregnancy with foetus known to be non-viable.
* Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
* Use of any investigational or non-registered product (drug or vaccine) during the study period.
For Non-exposed vaccinated cohort:
* Ongoing pregnancy with foetus known to be non-viable.
* Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
* Use of any investigational or non-registered product (drug or vaccine) during the study period.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
25 Years
Study:
NCT01290393
Study Brief:
Protocol Section:
NCT01290393