Who is sponsoring NCT00883012?

NCT00883012 is sponsored by University of Witwatersrand, South Africa.

What condition does NCT00883012 study?

NCT00883012 studies Influenza With Pneumonia, Influenza Virus Identified.

What drugs are being tested in NCT00883012?

Interventions: Trivalent sub-unit influenza vaccine, Saline, 0.5ml.

What is the status of NCT00883012?

NCT00883012 is currently COMPLETED.

Last reviewed 2012-04-02 · How we verify

Immunogenicity, Safety and Efficacy of Influenza Vaccine in HIV Infected Children

NCT00883012 Phase 4 COMPLETED

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 implemented as routine care, due to the lack of data on disease burden and vaccine efficacy. This study aims at determining the effectiveness of influenza vaccination in HIV infected children in South Africa.

Details

Lead sponsor	University of Witwatersrand, South Africa
Phase	Phase 4
Status	COMPLETED
Enrolment	412
Start date	2009-02
Completion	2010-06

Conditions

Influenza With Pneumonia, Influenza Virus Identified

Interventions

Trivalent sub-unit influenza vaccine
Saline, 0.5ml

Primary outcomes

Determine the efficacy of a tri-valent influenza sub-unit vaccine, in HIV infected children with a CD4+ percentage >15% against vaccine-strain viral confirmed influenza illness. — One year
Define the immunogenicity of influenza vaccination in a nested cohort of HIV infected children with CD4+ percentage >15% that are naïve to anti-retroviral or on antiretroviral therapy for more than 3 months — One year

Countries

South Africa