Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study.A(H1N1)v-pandemiarokotuskampanjan vaikutukset - Pandemiarokotuskampanjatutkimus

• Conditions: Influenza caused by the new A(H1N1)v influenza virus (swine influenza); MedDRA version: 12.0Level: LLTClassification code 10022001Term: Influenza (epidemic)

• Registration Number: EUCTR2009-015700-26-FI
• Lead Sponsor: ational Institute for Health and Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-29
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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:
oprevious severe allergic reaction to influenza vaccines or known severe allergy to the ingredients of the vaccine
oprevious severe allergic reaction to eggs
osignificant immunological disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified