Evaluation of Pandemic Vaccination Campaign

Completed

• Conditions: Influenza Caused by the Novel A(H1N1)v Influenza Virus

• Registration Number: NCT01024725
• Lead Sponsor: Finnish Institute for Health and Welfare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2010-04
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3518

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults	3 November 2009 to 30 April 2010

Secondary Outcome Measures

Name	Time	Method
Safety of vaccination with the A(H1N1)v vaccine	3 November 2009 to 31 October-November 2010
Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)	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
Effectiveness of the vaccine in subgroups	3 November 2009 to 31 October-November 2010

Trial Locations

Locations (1)

National Institute for Health and Welfare; 🇫🇮 Tampere, Finland