Status:
COMPLETED
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Influenza
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine ...
Detailed Description
Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00091702
End Date
January 1 2006
Last Update
November 1 2021
Active Locations (61)
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1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
2
Univ. of South Alabama College of Medicine, Southeast Ped. ACTU
Mobile, Alabama, United States
3
Phoenix Children's Hosp.
Phoenix, Arizona, United States, 85006
4
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801