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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021033-30 | EudraCT Number | ||
| R10075M | Other Identifier | The ethics committee of the Pirkanmaa Hospital District (PSHP) | |
| 81/2010 | Other Identifier | Finnish Medicines Agency |
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A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.
In the beginning of the study, changes in the background information collected in the original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza vaccinations is collected with vaccination cards and monthly short message service (SMS), and verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in Finland, the participants are asked to actively report symptoms of influenza like illnesses (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009 H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated persons | The participants have taken one or more doses of 2009 H1N1 vaccine, either as a monovalent vaccine or as a part of a trivalent seasonal 2010-2011 influenza vaccine |
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| Not (yet) vaccinated persons | The participants do not want to take any 2009 H1N1 vaccine or have not received any yet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up | Other | Questionnaires, interviews, nasal/oral and serum samples, register data |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 virus during the season 2010-11 among vaccinated adults as compared to unvaccinated adults | September 2010 to April 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza | September 2010 to April 2011 | |
| To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age | September 2010 to April 2011 |
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Inclusion criteria for the interview follow-up:
Inclusion criteria for the confirmation of 2009 H1N1 influenza cases:
Exclusion criteria:
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Participation in the study will be offered to all participants of the cohort study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" AH1N1-483-09THL, who still live in the study area (city of Tampere) and who have complied to the SMS or phone follow-up. The eligibility criteria of the original study AH1N1-483-09THL were: full legal competence; community-dwelling; age 18 to 75 years, written informed consent obtained; able to communicate fluently in Finnish or Swedish and able to adhere to all protocol required study procedures without any special burden or risk. Originally, 3500 persons participated in the study
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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
| Follow-up | Other | Questionnaires, interviews, nasal/oral and serum samples, register data |
|
| To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus | September 2010 to April 2011 |