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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01136057
Eligibility Criteria:
Inclusion Criteria:
* Currently healthy males 18 - 59 years of age with a history suggestive of having anti-influenza antibodies (either or both of the following):
1. An influenza-like illness (e.g., fever, chills, malaise, cough, myalgias, nausea). Subjects must asymptomatic and must be afebrile for ≥ 7 days, and must enroll within 12 months of onset of illness.
2. Vaccinated with a licensed influenza vaccine. Enrollment must occur \>14 days and \< 12 months from date of vaccination.
* Must be an adult male Department of Defense (DoD)/beneficiary
* Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
* A demonstrated H1N1 HAI titer of 1:160 or greater and H3N2 HAI titer of 1:40 or greater.
* Must also meet all Standard-of-Care inclusion criteria for donation of blood or plasma at the FDA-licensed donor center prior to every donation session. More information on this criterion can be found in the protocol.
Exclusion Criteria:
* Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.
* Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:
1. Anti-HIV-I/II
2. Anti-human T-lymphotropic virus (HTLV)-I/II
3. Anti-hepatitis C (HCV)
4. Anti-hepatitis B core antigen (HBc)
5. Anti-T. cruzi (enzyme immunoassay \[EIA\] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
6. Hepatitis B surface antigen (HBsAg)
7. Serologic test for syphilis
8. HIV nucleic acid test (NAT)
9. HCV NAT
10. West Nile virus (WNV) NAT
* Participation in other medical research that includes:
1. Studies that are currently ongoing or will start during the duration of this study that require more than 60 mL of blood to be donated in any 56-day period of time
2. Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
3. Administration of any unlicensed vaccine in the 12 months before study entry or during the duration of this study, with the exception of unlicensed influenza vaccine
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT01136057
Study Brief:
Protocol Section:
NCT01136057