Evaluation of Pandemic Vaccination Campaign

September 24, 2014 updated by: Finnish Institute for Health and Welfare

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3518

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33520
        • National Institute for Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
Vaccinated persons
The participants have taken the vaccine according to the national vaccination campaign
Other: Follow-up
Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
3 November 2009 to 30 April 2010

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety of vaccination with the A(H1N1)v vaccine
Time Frame: 3 November 2009 to 31 October-November 2010
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
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
3 November 2009 to 31 October-November 2010
Effectiveness of the vaccine in subgroups
Time Frame: 3 November 2009 to 31 October-November 2010
3 November 2009 to 31 October-November 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Finnish Institute for Health and Welfare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terhi M Kilpi, MD PhD, Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AH1N1-483-09THL
  • EudraCT 2009-015700-26 (Other Identifier: NAM Finland)
  • ETL R09152M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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