Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01022905
First received: November 30, 2009
Last updated: February 26, 2010
Last verified: February 2009

November 30, 2009
February 26, 2010
November 2009
February 2010   (final data collection date for primary outcome measure)
Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01022905 on ClinicalTrials.gov Archive Site
  • Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]
  • Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: Yes ]
  • T cell responses [ Time Frame: 4-6 wks after immunization ] [ Designated as safety issue: No ]
  • Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]
  • Solicited adverse events [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: Yes ]
  • T cell responses [ Time Frame: 4-6 wks after immunization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
Prospective Cohort Study of the Influence of Age, Underlying Disease and Immunosuppression on Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients.

The objective of this study is to assess vaccine responses to novel adjuvanted influenza A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.

This prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250 controls to whom influenza A(H1N1) immunization was recommended.

Six cohort have been established, enrolling patients with HIV infection, rheumatic diseases, organ transplant, cancer, pediatric patients and healthy controls.

Subjects will be assessed for specific antibody responses (all), T cell responses (subset) and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of immunization on underlying diseases (HIV infected patients, patients with auto-immune diseases) or graft function (transplant patients) - as appropriate.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infection
  • Rheumatic Disease
  • Cancer
  • Transplant
  • Pediatrics
Biological: Adjuvanted influenza A(H1N1) vaccines
Immunization (1-2 doses)
Other Names:
  • Pandemrix (GSK)
  • Focetria (Novartis)
  • Experimental: High-risk patients ( 5 cohorts)
    Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines
  • Active Comparator: Healthy controls
    Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1141
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • medically recommended influenza A(H1N1) immunization
  • signed informed consent

Exclusion Criteria:

  • failure or refusal to provide sufficient blood for antibody determination
Both
6 Months and older
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01022905
CER-09-234
No
Prof. Claire-Anne Siegrist, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Not Provided
University Hospital, Geneva
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP