Evaluation of Pandemic Vaccination Campaign
This study is ongoing, but not recruiting participants.
Sponsor:
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01024725
First received: November 2, 2009
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Caused by the Novel A(H1N1)v Influenza Virus |
Other: Follow-up |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study |
Resource links provided by NLM:
Further study details as provided by National Institute for Health and Welfare, Finland:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety of vaccination with the A(H1N1)v vaccine [ Time Frame: 3 November 2009 to 31 October-November 2010 ] [ Designated as safety issue: Yes ]
- Severity and possible complications of the A(H1N1)v influenza [ Time Frame: 3 November 2009 to 31 October-November 2010 ] [ Designated as safety issue: Yes ]
- Humoral and cellular immune responses to the vaccine (subgroup of 200 adults) [ Time Frame: 3 November 2009 to 31 October-November 2010 ] [ Designated as safety issue: Yes ]
- Effectiveness of the vaccine in subgroups [ Time Frame: 3 November 2009 to 31 October-November 2010 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
nasal/oral swabs, serum samples and peripheral blood mononuclear cells
| Estimated Enrollment: | 4000 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| 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.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024725
Locations
| Finland | |
| National Institute for Health and Welfare | |
| Tampere, Finland, 33520 | |
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Investigators
| Principal Investigator: | Terhi M Kilpi, MD PhD | National Institute for Health and Welfare, Finland |
More Information
No publications provided
| Responsible Party: | National Institute for Health and Welfare, Finland |
| ClinicalTrials.gov Identifier: | NCT01024725 History of Changes |
| Other Study ID Numbers: | AH1N1-483-09THL, EudraCT 2009-015700-26, ETL R09152M |
| Study First Received: | November 2, 2009 |
| Last Updated: | March 27, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by National Institute for Health and Welfare, Finland:
|
A(H1N1)v influenza vaccination pandemic |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013