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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01338051
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria (adult)
1. Non pregnant women 30-45 years of age in Manchay, and in Iquitos, with female children or grandchildren ages 10-13 who they are willing to enroll in the study to receive Gardasil vaccination.
2. No screening or knowledge of the results of a Pap Test in the last 5 years
3. No hysterectomy
4. No prior pelvic radiation.
5. Willing to sign consent form
Inclusion criteria (children)
1. Female children and grandchildren of a participating women ages 10-13 years
2. No acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
3. No previous vaccination with Gardasil
4. No reactions to previous dose in their vaccination series
5. No known yeast allergy
6. Willing to participate
Exclusion Criteria:
Exclusion criteria (adults)
Patients will be excluded in the study based on the following criteria:
1. Males
2. Women younger than 30 years old and older than 45 years old.
3. Women without female children or grandchildren age 10-13 or who are unwilling to enroll their 10-13 year old female children or grandchildren to receive Gardasil.
4. Pregnant women.
5. Patients with known history of hysterectomy or radiation for a pelvic cancer.
6. Refusal to participate
Exclusion criteria (Children)
1. Males
2. Girls younger than 10 years old, and older than 13 years.
3. acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
4. previous vaccination with Gardasil
5. reactions to a previous dose in their vaccination series
6. known yeast allergy
7. Refusal to participate
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
45 Years
Study:
NCT01338051
Study Brief:
Protocol Section:
NCT01338051