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

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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

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.

Condition or disease Intervention/treatment Phase
HIV Infection Rheumatic Disease Cancer Transplant Pediatrics Biological: Adjuvanted influenza A(H1N1) vaccines Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1141 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : November 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: High-risk patients ( 5 cohorts) Biological: Adjuvanted influenza A(H1N1) vaccines
Immunization (1-2 doses)
Other Names:
  • Pandemrix (GSK)
  • Focetria (Novartis)

Active Comparator: Healthy controls Biological: Adjuvanted influenza A(H1N1) vaccines
Immunization (1-2 doses)
Other Names:
  • Pandemrix (GSK)
  • Focetria (Novartis)




Primary Outcome Measures :
  1. Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ]

Secondary Outcome Measures :
  1. Antibody responses (neutralization) [ Time Frame: 4-6 weeks after immunization ]
  2. 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 ]
  3. T cell responses [ Time Frame: 4-6 wks after immunization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • failure or refusal to provide sufficient blood for antibody determination

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 ClinicalTrials.gov identifier (NCT number): NCT01022905


Locations
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Claire-Anne Siegrist, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01022905     History of Changes
Other Study ID Numbers: CER-09-234
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: March 1, 2010
Last Verified: February 2009

Keywords provided by University Hospital, Geneva:
HIV infection
transplant
rheumatic disease
cancer
children

Additional relevant MeSH terms:
HIV Infections
Rheumatic Diseases
Collagen Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs