NCT01206114|Completed
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · The ethics committee of the Pirkanmaa Hospital District (PSHP)
OTHER · Finnish Medicines Agency
observational
2,351
1 country
1
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2011
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2010
Actual (reported)September 21, 2010
Actual (reported)April 2011
Actual (reported)September 2014
Actual (reported)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
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
To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus
September 2010 to April 2011
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
The participants do not want to take any 2009 H1N1 vaccine or have not received any yet
Questionnaires, interviews, nasal/oral and serum samples, register data
Questionnaires, interviews, nasal/oral and serum samples, register data
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
National Institute for Health and Welfare
Tampere, 33520, Finland
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.
nasal/oral swabs, serum samples
Terhi M Kilpi, MD, PhD
Finnish Institute for Health and Welfare
2,351 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2010
First Posted
September 21, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation
Contact the study team to confirm eligibility.
Primary Completion
April 2011
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
September 25, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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