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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT01078220
Eligibility Criteria:
Inclusion Criteria:
3-Dose Safety Population
* Female 9-26 years at the time of first dose of GARDASIL™
* Completed the 3-dose regimen of GARDASIL™ per protocol
Pregnancy Safety Population
* Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution
Autoimmune Safety Population
* Female who has received at least one dose of GARDASIL™
* Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™
Any Dose Safety Population
* Female who has received at least one dose of GARDASIL™
Exclusion Criteria:
3-Dose Safety Population
* Male
* Receives incomplete regimen of GARDASIL™
* Completes the three dose regimen of GARDASIL™ in more than 12 months
* Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
* Younger than 9 or older than 26 years of age at receipt of first dose
Pregnancy Safety Population
* Males
* No record of pregnancy at the Managed Care Organization (MCO)
Autoimmune Safety Population
* Member of the same MCO for less than 12 months prior to receiving the first dose
* Male
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
9 Years
Study:
NCT01078220
Study Brief:
Protocol Section:
NCT01078220