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.
6 Months
N/A
Both
HIV Infection, Rheumatic Disease, Cancer, Transplant, Pediatrics
Trial Information
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.
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.
Inclusion Criteria:
- medically recommended influenza A(H1N1) immunization
- signed informed consent
Exclusion Criteria:
- failure or refusal to provide sufficient blood for antibody determination
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Antibody responses (inhibition of hemagglutination)
Outcome Time Frame:
4-6 weeks after immunization
Safety Issue:
No
Authority:
Switzerland: Swissmedic
Study ID:
CER-09-234
NCT ID:
NCT01022905
Start Date:
November 2009
Completion Date:
February 2010
Related Keywords:
- HIV Infection
- Rheumatic Disease
- Cancer
- Transplant
- Pediatrics
- HIV infection
- transplant
- rheumatic disease
- cancer
- children
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Influenza, Human
- Rheumatic Diseases
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