Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Study Overview
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Brief Summary
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Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects

Detailed Description
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The investigators will conduct a safety and immunogenicity study in health employees as detailed below: Examine adverse events of all employees after vaccination using adverse events form Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 & 42 after vaccination (up to 500 people) Provide a detailed time course of the immune response to vaccination with a novel influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses in 50 volunteers Investigate the long lasting immunity induced by the vaccine Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.

Official Title
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Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Conditions
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Healthy

Intervention / Treatment
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* Biological: Adjuvanted influenza H1N1split virion vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study Exclusion Criteria: Persons with a history of anaphylaxis or serious reactions to any vaccine Person with known hypersensitivity to any of the vaccine components Persons who have had a temperature >38oC during the previous 72 hours Persons who have had an acute respiratory infection during the last 7 days Suspected non-compliance

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pandemic influenza H1N1 vaccine<br>Influenza vaccine | Biological: Adjuvanted influenza H1N1split virion vaccine<br>* Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A) * Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)<br>* Other names: Pandemrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local and Systemic Adverse Events | Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination. | 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay | Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response | 7, 14, 21 days post vaccination and long term follow up for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H1N1 pandemic vaccine immunogenicity safety, Health employees