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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Antibody responses (inhibition of hemagglutination)
4-6 weeks after immunization