Evaluation of Pandemic Vaccination Campaign

Study Overview
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Brief Summary
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A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the disease are followed primarily from health care registers. In a subgroup of 200 participants, the humoral and cellular immunogenicity of the vaccine will be studied.

Official Title
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Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study

Conditions
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Influenza Caused by the Novel A(H1N1)v Influenza Virus

Intervention / Treatment
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* Other: Follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full legal competence; Written informed consent obtained; Assigned to use the services of Tampere health centre and community-dwelling; At least 18 and no more than 75 years old, inclusive; Belongs to the target group of A(H1N1)v vaccination in the region during the pandemic vaccination campaign; Able to communicate fluently in Finnish or Swedish Able to adhere to all protocol required study procedures without any special burden or risk, as judged by the investigator or designate. Exclusion Criteria: For the total study cohort, no specific exclusion criteria will be applied; For the subgroup for follow-up of immunogenicity of the vaccine (immunogenicity cohort), exclusion criteria comprise: previous severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine previous severe allergic reaction to eggs significant immunological disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Not (yet) vaccinated persons<br>The participants do not want to take the vaccine (available only in the national vaccination campaign) or have not received it yet | Other: Follow-up<br>* Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data<br>|
| Vaccinated persons<br>The participants have taken the vaccine according to the national vaccination campaign | Other: Follow-up<br>* Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults |  | 3 November 2009 to 30 April 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vaccination with the A(H1N1)v vaccine |  | 3 November 2009 to 31 October-November 2010 | 
| Severity and possible complications of the A(H1N1)v influenza |  | 3 November 2009 to 31 October-November 2010 | 
| Humoral and cellular immune responses to the vaccine (subgroup of 200 adults) |  | 3 November 2009 to 31 October-November 2010 | 
| Effectiveness of the vaccine in subgroups |  | 3 November 2009 to 31 October-November 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A(H1N1)v influenza, vaccination, pandemic