Evaluation of Pandemic Vaccination Campaign

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza Caused by the Novel A(H1N1)v Influenza Virus

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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

Follow-up

Intervention Type OTHER

Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data

Vaccinated persons

The participants have taken the vaccine according to the national vaccination campaign

Follow-up

Intervention Type OTHER

Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data

Interventions

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Follow-up

Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes