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

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Pediatrics; HIV Infection; Transplant; Rheumatic Disease; Cancer

Treatments: Biological: Adjuvanted influenza A(H1N1) vaccines

Study type: Interventional

Funder types: Other

Identifiers

NCT01022905

CER-09-234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,141 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• failure or refusal to provide sufficient blood for antibody determination

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,141 participants in 2 patient groups

High-risk patients ( 5 cohorts)

Experimental group

Treatment:

Biological: Adjuvanted influenza A(H1N1) vaccines

Healthy controls

Active Comparator group

Treatment:

Biological: Adjuvanted influenza A(H1N1) vaccines