Evaluation of Pandemic Vaccination Campaign

Finnish Institute for Health and Welfare

Status

Completed

Conditions

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

Treatments

Other: Follow-up

Study type

Observational

Funder types

Other

Identifiers

NCT01024725

ETL R09152M

EudraCT 2009-015700-26 (Other Identifier)

AH1N1-483-09THL

Details and patient eligibility

About

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.

Enrollment

3,518 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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