Influenza Caused by the 2009 H1N1 Influenza VirusNCT01206114
Evaluation of the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11
An observational study of Influenza Caused by the 2009 H1N1 Influenza Virus, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11. Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Caused by the 2009 H1N1 Influenza Virus
- What is being tested?
- Follow-up
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 2,351 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to 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 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participation in the study will be offered to all participants of the cohort study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" AH1N1-483-09THL, who still live in the study area (city of Tampere) and who have complied to the SMS or phone follow-up. The eligibility criteria of the original study AH1N1-483-09THL were: full legal competence; community-dwelling; age 18 to 75 years, written informed consent obtained; able to communicate fluently in Finnish or Swedish and able to adhere to all protocol required study procedures without any special burden or risk. Originally, 3500 persons participated in the study
Who may be able to join
- Participating in the study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" (AH1N1-483-09THL)
- Assigned to use the services of Tampere health care centre;
- Written consent for the interview follow-up phase obtained by mail;
- Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself
- Inclusion criteria for the confirmation of 2009 H1N1 influenza cases:
- Participating in the study interview follow-up of the current study 'Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL)
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- Assigned to use the services of Tampere health care centre
- Written informed consent for the confirmation phase obtained at the first study visit
- 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
- No specific exclusion criteria will be applied
Trial locations and contacts
1 site in 1 country.
About this study
A cohort of 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.
Read the detailed description
In the beginning of the study, changes in the background information collected in the original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza vaccinations is collected with vaccination cards and monthly short message service (SMS), and verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in Finland, the participants are asked to actively report symptoms of influenza like illnesses (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009 H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.
- Being tested
- Follow-up
- Keywords
- 2009 H1N1 influenza, vaccination, pandemic, effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Questionnaires, interviews, nasal/oral and serum samples, register data
Follow-upOther
Questionnaires, interviews, nasal/oral and serum samples, register data
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated persons | The participants have taken one or more doses of 2009 H1N1 vaccine, either as a monovalent vaccine or as a part of a trivalent seasonal 2010-2011 influenza vaccine Receives: Other: Follow-up | |
| Not (yet) vaccinated persons | The participants do not want to take any 2009 H1N1 vaccine or have not received any yet Receives: Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 virus during the season 2010-11 among vaccinated adults as compared to unvaccinated adults
Measured: September 2010 to April 2011
Secondary outcomes (3)
To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza
Measured: September 2010 to April 2011
To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age
Measured: September 2010 to April 2011
To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus
Measured: September 2010 to April 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- 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 2009 H1N1 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,351 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
- NCT01206114
- Sponsor's protocol ID
- H1N1-495-10THL
- Other IDs
- 2010-021033-30, R10075M, 81/2010
- Status last verified
- Sep 2014
- First submitted
- 20 Sep 2010
- 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 the Effectiveness of Vaccination With 2009 H1N1 Vaccines During Influenza Season 2010-11
- ClinicalTrials.gov ID
- NCT01206114
- Acronym / sponsor ID
- H1N1-495-10THL
- Keywords
- 2009 H1N1 influenza, vaccination, pandemic, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,351 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Sep 2010 (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 3000 adults is followed to evaluate the effectiveness of the monovalent 2009 H1N1 vaccines used 2009-2010 and seasonal influenza vaccines used 2010-2011 in preventing the first laboratory-confirmed 2009 H1N1 influenza during the influenza season 2010-11.
Detailed description
In the beginning of the study, changes in the background information collected in the original study (conducted 2009-2010) are asked with a questionnaire. Information on influenza vaccinations is collected with vaccination cards and monthly short message service (SMS), and verified in registers, if needed. If an epidemic caused by the 2009 H1N1 virus starts in Finland, the participants are asked to actively report symptoms of influenza like illnesses (ILI). The symptoms are also monitored by weekly SMS. In case of ILI, nasal and oral swabs are collected to verify the 2009 H1N1 influenza cases. Paired serum samples are collected at the acute on convalescence phase of the disease. The occurrence of laboratory-confirmed 2009 H1N1 influenza cases is compared between vaccinated and not (yet) vaccinated persons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated persons | – | Other: Follow-upThe participants have taken one or more doses of 2009 H1N1 vaccine, either as a monovalent vaccine or as a part of a trivalent seasonal 2010-2011 influenza vaccine |
| Not (yet) vaccinated persons | – | Other: Follow-upThe participants do not want to take any 2009 H1N1 vaccine or have not received any yet |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study will be offered to all participants of the cohort study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" AH1N1-483-09THL, who still live in the study area (city of Tampere) and who have complied to the SMS or phone follow-up. The eligibility criteria of the original study AH1N1-483-09THL were: full legal competence; community-dwelling; age 18 to 75 years, written informed consent obtained; able to communicate fluently in Finnish or Swedish and able to adhere to all protocol required study procedures without any special burden or risk. Originally, 3500 persons participated in the study
Key inclusion criteria (9 listed)
- Participating in the study "Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study" (AH1N1-483-09THL)
- Assigned to use the services of Tampere health care centre;
- Written consent for the interview follow-up phase obtained by mail;
- Able to adhere to all protocol-required study procedures without any special burden or risk, as judged by the participant himself/herself
- Participating in the study interview follow-up of the current study 'Evaluation the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 (H1N1-495-10THL)
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied
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-upQuestionnaires, interviews, nasal/oral and serum samples, register data | Other | Vaccinated persons |
| Follow-upQuestionnaires, interviews, nasal/oral and serum samples, register data | Other | Not (yet) vaccinated persons |
Primary outcome
To determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 virus during the season 2010-11 among vaccinated adults as compared to unvaccinated adults
Time frame: September 2010 to April 2011
3 secondary outcomes
To explore the ability of different vaccination regimens to prevent 2009 H1N1 influenza
Time frame: September 2010 to April 2011
To explore the effectiveness of the 2009 H1N1 vaccines in subgroups stratified by age
Time frame: September 2010 to April 2011
To evaluate the incidence, severity and possible complications of laboratory-confirmed infection with the 2009 H1N1 influenza virus
Time frame: September 2010 to April 2011
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 2009 H1N1 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 9 inclusion and 1 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?
To determine the effectiveness of 2009 H1N1 influenza vaccination in preventing the first episode of laboratory-confirmed influenza caused by the 2009 H1N1 virus during the season 2010-11 among vaccinated adults as compared to unvaccinated adults (time frame: September 2010 to April 2011). 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 NCT01206114, 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.