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

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

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 Intervention Phase
HIV Infection
Rheumatic Disease
Biological: Adjuvanted influenza A(H1N1) vaccines
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Antibody responses (inhibition of hemagglutination) [ Time Frame: 4-6 weeks after immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1141
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.


Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • failure or refusal to provide sufficient blood for antibody determination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01022905

University Hospitals of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Prof. Claire-Anne Siegrist, University Hospital, Geneva Identifier: NCT01022905     History of Changes
Other Study ID Numbers: CER-09-234
Study First Received: November 30, 2009
Last Updated: February 26, 2010
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Musculoskeletal Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on February 25, 2015