Influenza Caused by the Novel A(H1N1)v Influenza VirusNCT01024725
Evaluation of Pandemic Vaccination Campaign
An observational study of Influenza Caused by the Novel A(H1N1)v Influenza Virus, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Caused by the Novel A(H1N1)v Influenza Virus
- What is being tested?
- Follow-up
- Type of treatment
- Vaccines
- How many people
- 3,518 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2009to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Follow-up
- Keywords
- A(H1N1)v influenza, vaccination, pandemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Nasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Follow-up | |
| Vaccinated persons | The participants have taken the vaccine according to the national vaccination campaign Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of vaccination in preventing the first episode of laboratory-confirmed A(H1N1)v infection in adults
Measured: 3 November 2009 to 30 April 2010
Secondary outcomes (4)
Safety of vaccination with the A(H1N1)v vaccine
Measured: 3 November 2009 to 31 October-November 2010
Severity and possible complications of the A(H1N1)v influenza
Measured: 3 November 2009 to 31 October-November 2010
Humoral and cellular immune responses to the vaccine (subgroup of 200 adults)
Measured: 3 November 2009 to 31 October-November 2010
Effectiveness of the vaccine in subgroups
Measured: 3 November 2009 to 31 October-November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Caused by the Novel A(H1N1)v Influenza VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Terhi M Kilpi, MD PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024725
- Sponsor's protocol ID
- AH1N1-483-09THL
- Other IDs
- EudraCT 2009-015700-26, ETL R09152M
- Status last verified
- Sep 2014
- First submitted
- 2 Nov 2009
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25265186
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Vaccination Campaign With A(H1N1)v Pandemic Vaccines: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01024725
- Acronym / sponsor ID
- AH1N1-483-09THL
- Keywords
- A(H1N1)v influenza, vaccination, pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,518 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not (yet) vaccinated persons | – | Other: Follow-upThe participants do not want to take the vaccine (available only in the national vaccination campaign) or have not received it yet |
| Vaccinated persons | – | Other: Follow-upThe participants have taken the vaccine according to the national vaccination campaign |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-upNasopharyngeal/oropharyngeal and blood samples, interviews, questionnaires, register data | Other | Not (yet) vaccinated persons, Vaccinated persons |
Primary outcome
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
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Derived from this study: PubMed 25265186Syrjanen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terhi M Kilpi, MD PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Caused by the Novel A(H1N1)v Influenza Virus, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.