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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT02000466
Eligibility Criteria:
Inclusion Criteria:
A subject will be included in the Registry if all of the following criteria are met:
* Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
* Subject is a US resident.
* A HCP is identified (name, address and phone number).
* Subject can be identified (by GSK or HCP).
Data from registered subjects will be included in the analyses if the following criterion is met:
• Pregnancy is ongoing and the outcome is unknown.
Exclusion Criteria:
Data from registered subjects will not be included in the analyses if the following criterion is met:
• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
64 Years
Study:
NCT02000466
Study Brief:
Protocol Section:
NCT02000466