Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

Study Overview
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Brief Summary
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Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study. The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.

Detailed Description
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Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study. Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined. The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.

Official Title
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Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

Conditions
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Organ Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Cohort number 1: Organ transplant patients who were vaccinated with Pandemrix 2009 and written informed consent received Cohort number 2: Staff members who were vaccinated with Pandemrix 2009 and written informed consent received Exclusion Criteria: Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| organ transplant patients<br> | |
| healthy controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination |  | February 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2009 H1N1 influenza vaccine, organ transplant patients,, booster with Fluarix