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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT02568566
Eligibility Criteria:
Inclusion Criteria:
* Healthy, medically well girls and boys
* Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
* Ability to understand and the willingness to sign a written assent document by the participant
Exclusion Criteria:
* Previous vaccination against HPV
* The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
* Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
* Receiving active treatment for cancer or an autoimmune condition
* Confirmed or suspected immunosuppressive or immunodeficient condition
* Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
* History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy
* Are pregnant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
11 Years
Study:
NCT02568566
Study Brief:
Protocol Section:
NCT02568566