NCT01022905

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,141 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infection
• Rheumatic Disease
• Cancer
• Transplant
• Pediatrics

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted influenza A(H1N1) vaccines	Immunization (1-2 doses)

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-12-01
• Last updated: 2010-03-01

Locations

1 site across 1 country: Switzerland