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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT03355820
Eligibility Criteria:
Inclusion Criteria:
* Subjects/subject's parents/legally acceptable representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject or subject's parents/LAR(s) prior to performing any study specific procedure.
* Written informed assent obtained from the subjects below the legal age of consent.
* Subjects who received all three doses of the HPV-16/18 vaccine in the HPV-058 study.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine which may have an impact on the study objectives) during the period starting 30 days (Day 29 to Day 1) before the study visit.
* Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Previous vaccination against HPV outside the HPV-058 study.
* Subjects with contraindications related to blood draw such as blood disorders and anticoagulants use.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
17 Years
Study:
NCT03355820
Study Brief:
Protocol Section:
NCT03355820