Status:
COMPLETED
Influenza Vaccine in HIV Infected Children
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Influenza With Pneumonia, Influenza Virus Identified
Eligibility:
All Genders
6-5 years
Phase:
PHASE4
Brief Summary
Influenza associated pneumonia causes significant morbidity in young HIV-infected children. Although annual vaccination against influenza is recommended for HIV infected children, it has not been impl...
Detailed Description
Influenza virus infects 30 to 50% of children under five years of age during the course of any epidemic. The attack rates of influenza virus associated illness during infancy remains high, and at leas...
Eligibility Criteria
Inclusion
- HIV infected children with CD4% ≥ 15% performed within the previous 3 months in relation to the date of randomization.
- Age 6 month- 5 years old.
- Willing and able to maintain weekly contact at least during period of April - August (i.e. presupposed influenza period) either through SMS or telephonic contact.
- Willing and able to adhere to study protocol re: attendance to clinic for scheduled and illness visits.
Exclusion
- Any contraindication to influenza vaccination, including known allergy to egg.
- History of chronic lung disease which required maintenance therapy either currently or in the past 6 months.
- Any contraindication to intramuscular injections.
- Current known grade 3 or grade 4 laboratory or clinical toxicity as per DAIDS toxicity tables.
- Any previous history of influenza vaccination.
- Plan to emigrate from the study area within the next year.
- On steroid therapy for \> 21 days (current or within the past 30 days).
- In the investigators opinion unable to maintain study procedures.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00883012
Start Date
February 1 2009
End Date
June 1 2010
Last Update
April 3 2012
Active Locations (1)
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1
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa, 2013