Evaluation of the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-112009 H1N1-influenssarokotteiden tehokkuus influenssakaudella 2010-11 - Pandemiarokotuskampanjan jatkotutkimus

• Conditions: Influenza caused by the 2009 H1N1 influenza virus (swine influenza); MedDRA version: 12.1Level: LLTClassification code 10022001Term: Influenza (epidemic)

• Registration Number: EUCTR2010-021033-30-FI
• Lead Sponsor: ational Institute for Health and Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Inclusion criteria for the interview follow-up
•Participating in the study Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study” (AH1N1-483-09THL);
•Assigned to use the services of Tampere health care centre;
•Written consent for the interview follow-up phase obtained by mail;
•Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself

Inclusion criteria for the confirmation of 2009 H1N1 influenza cases
•Participating in the study interview follow-up of the current study ‘Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL)
•Assigned to use the services of Tampere health care centre;
•Written informed consent for the confirmation phase obtained at the first study visit;
•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

•no specific exclusion criteria will be applied

Study & Design

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