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Influenza Vaccine in HIV Infected Children

NCT00883012 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2012-04-03

No results posted yet for this study

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 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.

Conditions

  • Influenza With Pneumonia, Influenza Virus Identified

Interventions

BIOLOGICAL

Trivalent sub-unit influenza vaccine

Composition per 0.5 ml dose: Active substance: Split Influenza virus\*, inactivated Strains for 2009 Southern hemisphere A/Brisbane/59/2007- like (H1N1) 15 micrograms\*\*, A/Brisbane/10/2007 (H3N2) - like strain (A/Brisbane/10/2007 (IVR-147) 15 micrograms\*\*, B/Florida/4/2006 - like strain (B/Brisbane/3/2007)15 micrograms\*\* Two doses, one month apart

BIOLOGICAL

Saline, 0.5ml

Saline IMI, 0.5ml. Two doses one month apart

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Shabir A Madhi, MD, PhD · VPD- RMPRU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-12-31
Completion
2010-06-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883012 on ClinicalTrials.gov