Influenza Vaccine in HIV Infected Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883012
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 3, 2012
Information provided by (Responsible Party):
Michelle Groome, University of Witwatersrand, South Africa

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 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.

Condition or disease Intervention/treatment Phase
Influenza With Pneumonia, Influenza Virus Identified Biological: Trivalent sub-unit influenza vaccine Biological: Saline, 0.5ml Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Efficacy of Influenza Vaccine in HIV Infected Children
Study Start Date : February 2009
Primary Completion Date : December 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Influenza vaccine
Two doses of trivalent sub-unit influenza vaccine (2009) to be administered one month apart
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

Placebo Comparator: Placebo
Two doses of saline administered one month apart
Biological: Saline, 0.5ml
Saline IMI, 0.5ml. Two doses one month apart

Primary Outcome Measures :
  1. 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. [ Time Frame: One year ]
  2. 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 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Determine the safety of influenza vaccination in relation to solicited vaccine-related adverse events in the 72 hour period post-vaccination and any other unsolicited adverse event. [ Time Frame: One year ]
  2. Compare the effect of the influenza vaccination on viral control and CD4+ cell count in HIV infected children six months following influenza vaccination. [ Time Frame: One year ]

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883012

South Africa
Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa, 2013
Sponsors and Collaborators
University of Witwatersrand, South Africa
Principal Investigator: Shabir A Madhi, MD, PhD VPD- RMPRU

Responsible Party: Michelle Groome, Investigator, University of Witwatersrand, South Africa Identifier: NCT00883012     History of Changes
Other Study ID Numbers: Paediatric influenza vax
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

Keywords provided by Michelle Groome, University of Witwatersrand, South Africa:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Immunologic Factors
Physiological Effects of Drugs