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:
NCT02968420
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent provided by the participant.
* Participant whom the investigator believes can and will comply with the requirements of the protocol.
* General good health.
* Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01 study or the BC provincial program.
* Participant who is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Examples of effective methods of birth control include:
* Abstinence (no sexual activity)
* Hormonal contraceptives including oral, injectable, implants \& skin patches
* Intrauterine device (IUD)
* Male partner sterilization
* Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
* Male condom combined with a female diaphragm, whether with or without a vaginal spermicide (foam, gel, cream, or suppository)
* Adequate contraception does not apply to participants with same sex partners, when this is their preferred and usual lifestyle
Exclusion Criteria:
* Received more than 3 doses of Q-HPV vaccine
* Received any doses of HPV9 vaccine
* Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any previous dose of Q-HPV vaccine.
* Receipt of blood or blood product within 3 months prior to Visit 1.
* Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of Visit 1
* Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit 1.
* Inadequate participant fluency in English to provide fully informed consent.
* Participant who is currently pregnant or planning a pregnancy during the course of the trial
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
17 Years
Maximum Age:
35 Years
Study:
NCT02968420
Study Brief:
Protocol Section:
NCT02968420