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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2009-015700-26 | Other Identifier | NAM Finland | |
| ETL R09152M |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Not (yet) vaccinated persons | The participants do not want to take the vaccine (available only in the national vaccination campaign) or have not received it yet |
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| Vaccinated persons | The participants have taken the vaccine according to the national vaccination campaign |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up | Other | Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data |
|
| 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 |
| 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 |
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Inclusion Criteria:
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:
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The subjects will be invited from the population assigned to use the services of Tampere health centre, according to the target groups for pandemic vaccination. Invitations will be distributed at the maternity clinics for pregnant women, at work places for health professionals, and letters will be sent home to random sample of subjects at age groups of 18-24 years, 25-64 years and potetially later at 65-75 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Terhi M Kilpi, MD PhD | Finnish Institute for Health and Welfare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health and Welfare | Tampere | 33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25265186 | Derived | Syrjanen RK, Jokinen J, Ziegler T, Sundman J, Lahdenkari M, Julkunen I, Kilpi TM. Effectiveness of pandemic and seasonal influenza vaccines in preventing laboratory-confirmed influenza in adults: a clinical cohort study during epidemic seasons 2009-2010 and 2010-2011 in Finland. PLoS One. 2014 Sep 29;9(9):e108538. doi: 10.1371/journal.pone.0108538. eCollection 2014. |
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nasal/oral swabs, serum samples and peripheral blood mononuclear cells
| 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 |