Evaluation of Pandemic Vaccination Campaign

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01024725
First received: November 2, 2009
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Influenza Caused by the Novel A(H1N1)v Influenza Virus
Other: Follow-up
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Biospecimen Retention:   Samples With DNA

nasal/oral swabs, serum samples and peripheral blood mononuclear cells


Estimated Enrollment: 4000
Study Start Date: November 2009
Estimated Study Completion Date: January 2014
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024725

Locations
Finland
National Institute for Health and Welfare
Tampere, Finland, 33520
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
Principal Investigator: Terhi M Kilpi, MD PhD National Institute for Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01024725     History of Changes
Other Study ID Numbers: AH1N1-483-09THL, EudraCT 2009-015700-26, ETL R09152M
Study First Received: November 2, 2009
Last Updated: September 5, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by National Institute for Health and Welfare, Finland:
A(H1N1)v influenza
vaccination
pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014