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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT00091702
Eligibility Criteria:
Inclusion Criteria:
* HIV infected
* Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated
* Meet certain CD4 cell count and CD4% requirements
* Viral load of less than 60,000 copies/ml within 60 days prior to study start
* Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years
* Written informed consent of parent or legal guardian
* Availability of parent or legal guardian to be contacted by phone
Exclusion Criteria:
* Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing
* Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization
* History of hypersensitivity to any component of IAIV or FluMist
* History of Guillain-Barre syndrome
* Receipt of any inactivated vaccine within 14 days prior to the study vaccination
* Receipt of any live vaccine within 30 days prior to the study vaccination
* Plans to receive any vaccine within the 30 days following the vaccination
* Receipt of any additional influenza vaccine for the duration of the study
* Prophylactic use of drugs with anti-influenza activity
* Moderate chronic pulmonary disease, obstructive or restrictive
* Cardiopulmonary disease affecting normal childhood activity
* Medically-diagnosed wheezing, bronchodilator use, or steroid use within the past 42 days
* Medical illness associated with suppression of T-cell immunity
* Pregnancy, breast-feeding, or unwillingness to use acceptable methods of contraception for 3 months following vaccination
* Severely immunosuppressed household member
* Receipt of any blood products within 3 months prior to vaccination or expected receipt during the study, including the 6-month follow-up period
* Significant fever or illness within 72 hours prior to vaccination
* Any other condition that would interfere with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT00091702
Study Brief:
Protocol Section:
NCT00091702