Evaluation of Pandemic Vaccination Campaign

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01024725

Enrollment

3518

Registered

2009-12-03

Start date

2009-11-30

Completion date

2014-09-30

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

A(H1N1)v influenza, vaccination, pandemic

Brief summary

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.

Interventions

OTHERFollow-up

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults	3 November 2009 to 30 April 2010

Secondary

Measure	Time frame
Safety of vaccination with the A(H1N1)v vaccine	3 November 2009 to 31 October-November 2010
Severity and possible complications of the A(H1N1)v influenza	3 November 2009 to 31 October-November 2010
Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)	3 November 2009 to 31 October-November 2010
Effectiveness of the vaccine in subgroups	3 November 2009 to 31 October-November 2010

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026