NCT01024725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

November 2, 2009

Last Update Submit

September 24, 2014

Conditions

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

Keywords

A(H1N1)v influenzavaccinationpandemic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Not (yet) vaccinated persons

The participants do not want to take the vaccine (available only in the national vaccination campaign) or have not received it yet

Other: Follow-up

Vaccinated persons

The participants have taken the vaccine according to the national vaccination campaign

Other: Follow-up

Interventions

Follow-upOTHER

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

Not (yet) vaccinated personsVaccinated persons

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects will be invited from the population assigned to use the services of Tampere health centre, according to the target groups for pandemic vaccination. Invitations will be distributed at the maternity clinics for pregnant women, at work places for health professionals, and letters will be sent home to random sample of subjects at age groups of 18-24 years, 25-64 years and potetially later at 65-75 years of age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health and Welfare

Tampere, 33520, Finland

Location

Related Publications (1)

  • Syrjanen RK, Jokinen J, Ziegler T, Sundman J, Lahdenkari M, Julkunen I, Kilpi TM. Effectiveness of pandemic and seasonal influenza vaccines in preventing laboratory-confirmed influenza in adults: a clinical cohort study during epidemic seasons 2009-2010 and 2010-2011 in Finland. PLoS One. 2014 Sep 29;9(9):e108538. doi: 10.1371/journal.pone.0108538. eCollection 2014.

    PMID: 25265186DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

nasal/oral swabs, serum samples and peripheral blood mononuclear cells

Study Officials

  • Terhi M Kilpi, MD PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2009

First Posted

December 3, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

September 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

FI(1)