Completed

NCT Number: NCT01024725

Evaluation of Pandemic Vaccination Campaign

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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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Health and Welfare

Tampere, 33520, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up

Other

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

Primary outcomes

Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults

Time frame: 3 November 2009 to 30 April 2010

Secondary outcomes

Safety of vaccination with the A(H1N1)v vaccine

Time frame: 3 November 2009 to 31 October-November 2010
Severity and possible complications of the A(H1N1)v influenza

Time frame: 3 November 2009 to 31 October-November 2010
Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)

Time frame: 3 November 2009 to 31 October-November 2010
Effectiveness of the vaccine in subgroups

Time frame: 3 November 2009 to 31 October-November 2010

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Registry information

Official study title

Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2014
First posted: Dec 3, 2009
Registry last updated: Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.