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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07377656
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female individuals aged 9 months, 15 months, 2-5 years and unmarried females aged 15-20 years at the time of vaccination
* Participants aged 9 months, 15 months and 2-5 years who are up to date with their EPI vaccinations.
* Residing within the area of the study and planning to stay for the study duration.
* Participants that are HIV negative at screening (for the 9-15-month-olds a documented negative maternal ANC HIV screening).
* Unmarried females with a negative pregnancy test at screening practicing/willing to practice continuous effective contraception as recommended by the Ghana Health Services guidance in Ghana
* Able and willing to comply with all study requirements.
* Willingness to provide written informed consent before any trial procedure. Assent will be required for young female participants aged 15-17 years at vaccination in addition to their parent's/LAR's consent.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the study vaccine dose
* Previous vaccination against HPV (Only for the 15-20-year-old efficacy cohort)
* Presence of malnutrition (weight-for-length z-score ≤-2SD median, per WHO published child growth standards)
* Planning to migrate out of the study areas before the end of the study follow-up
* Any underlying known condition or criteria, including acute or chronic clinically significant abnormality or infection that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study.
* Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine.
* Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction.
* Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within 3 months prior to recruitment (topical steroids may be allowed).
* Any other finding that in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
20 Years
Study:
NCT07377656
Study Brief:
Protocol Section:
NCT07377656