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Evaluation of Pandemic Vaccination Campaign

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024725
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Finnish Institute for Health and Welfare

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Influenza Caused by the Novel A(H1N1)v Influenza Virus Other: Follow-up

Study Design
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Study Type : Observational
Actual Enrollment : 3518 participants
Time Perspective: Prospective
Official Title: Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study
Study Start Date : November 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Other: Follow-up
Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
Vaccinated persons
The participants have taken the vaccine according to the national vaccination campaign
 Other: Follow-up
Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults [ Time Frame: 3 November 2009 to 30 April 2010 ]

Secondary Outcome Measures :
  1. Safety of vaccination with the A(H1N1)v vaccine [ Time Frame: 3 November 2009 to 31 October-November 2010 ]
  2. Severity and possible complications of the A(H1N1)v influenza [ Time Frame: 3 November 2009 to 31 October-November 2010 ]
  3. Humoral and cellular immune responses to the vaccine (subgroup of 200 adults) [ Time Frame: 3 November 2009 to 31 October-November 2010 ]
  4. Effectiveness of the vaccine in subgroups [ Time Frame: 3 November 2009 to 31 October-November 2010 ]

Biospecimen Retention:   Samples With DNA
nasal/oral swabs, serum samples and peripheral blood mononuclear cells

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024725


Locations
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Finland
National Institute for Health and Welfare
Tampere, Finland, 33520
Sponsors and Collaborators
Finnish Institute for Health and Welfare
Investigators
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Principal Investigator: Terhi M Kilpi, MD PhD Finnish Institute for Health and Welfare
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Finnish Institute for Health and Welfare
ClinicalTrials.gov Identifier: NCT01024725    
Other Study ID Numbers: AH1N1-483-09THL
EudraCT 2009-015700-26 ( Other Identifier: NAM Finland )
ETL R09152M
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Finnish Institute for Health and Welfare:
A(H1N1)v influenza
vaccination
pandemic
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases