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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07493460
Eligibility Criteria:
Inclusion Criteria:
1. Healthy participants over 18 years of age.
2. Able to understand and give informed consent.
3. Willing to receive TIV, Tdap, HPV, and HAV vaccinations
4. In stable health, as determined by medical history and targeted physical exam related to this history.
5. Willing to give BMA samples
6. For those willing to give FNA or BMCB samples, Willing to:
give FNA specimens OR give BMCB specimens OR give both FNA and BMCB specimens
Exclusion Criteria:
1. Has a history of severe allergic reaction to any component of the TIV, Tdap, HPV, or HAV vaccines, including allergic reactions to neomycin, yeast or prior severe reaction after vaccination including anaphylaxis or encephalopathy within 7 days of vaccination.
2. Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
3. Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
4. Is acutely ill or febrile (temperature \>38.0 C \[100.4F\] less than 72 hours prior to or at the day 1 visit. Participants who meet this criteria may be rescheduled.
5. Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
6. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
7. Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
8. Has received the 2025-2026 influenza trivalent, inactivated vaccine or quadrivalent, inactivated vaccine.
9. Has received any quadrivalent or trivalent inactivated influenza, Tdap, HPV, or HAV vaccines ≤ 180 days prior to the injection (Day 1).
10. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
11. Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
12. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
13. Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core biopsy for participants willing to have those procedures done
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07493460
Study Brief:
Protocol Section:
NCT07493460