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

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.
 
ClinicalTrials.gov Identifier: NCT01022905
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : March 1, 2010
Sponsor:
Information provided by:
University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date March 1, 2010
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01022905 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2009)
  • Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ]
  • 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 ]
  • T cell responses [ Time Frame: 4-6 wks after immunization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ]
  • Solicited adverse events [ Time Frame: 4-6 weeks after immunization ]
  • T cell responses [ Time Frame: 4-6 wks after immunization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infection
  • Rheumatic Disease
  • Cancer
  • Transplant
  • Pediatrics
Intervention  ICMJE Biological: Adjuvanted influenza A(H1N1) vaccines
Immunization (1-2 doses)
Other Names:
  • Pandemrix (GSK)
  • Focetria (Novartis)
Study Arms  ICMJE
  • Experimental: High-risk patients ( 5 cohorts)
    Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines
  • Active Comparator: Healthy controls
    Intervention: Biological: Adjuvanted influenza A(H1N1) vaccines
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2010)
1141
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
1500
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • failure or refusal to provide sufficient blood for antibody determination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022905
Other Study ID Numbers  ICMJE CER-09-234
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Claire-Anne Siegrist, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date February 2009

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