Influenza H1N1NCT01178918
Non-specific Response to H1N1 Vaccine
An observational study of Influenza H1N1, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia. The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza H1N1
- How many people
- 14 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2009to 1 Jul 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
Who may be able to join
- Recipients of H1N1 influenza vaccine.
- Healthy individuals with no signs of influenza or other infectious disease.
Who cannot join
- Signs of influenza or other infectious disease in 1 month before study participation.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Clinic of Respiratory and Allergic Diseases
Golnik, 4204
About this study
Official title: Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.
- Conditions
- Influenza H1N1
- Keywords
- Influenza H1N1, Vaccine, Adjuvant, T Lymphocytes, Non-specific response, Interleukin-2, Non-specific T cell response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers from recipients of H1N1 vaccine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Measured: At 3 weeks after vaccination
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Measured: At 11 weeks after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startNov 2009
- Primary completion1 Dec 2010
- Study completion1 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza H1N1Studies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Korošec, The University Clinic of Pulmonary and Allergic Diseases Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178918
- Sponsor's protocol ID
- KOPA-H1N1-01
- Status last verified
- Feb 2020
- First submitted
- 4 Aug 2010
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
- ClinicalTrials.gov ID
- NCT01178918
- Acronym / sponsor ID
- KOPA-H1N1-01
- Conditions
- Influenza H1N1
- Keywords
- Influenza H1N1, Vaccine, Adjuvant, T Lymphocytes, Non-specific response, Interleukin-2, Non-specific T cell response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Jul 2012 (actual)
- First posted
- 10 Aug 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.
This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers from recipients of H1N1 vaccine | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
Key inclusion criteria (2 listed)
- Recipients of H1N1 influenza vaccine.
- Healthy individuals with no signs of influenza or other infectious disease.
Key exclusion criteria (1 listed)
- Signs of influenza or other infectious disease in 1 month before study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Time frame: At 3 weeks after vaccination
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
Time frame: At 11 weeks after vaccination.
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 28 Feb 2020.
Related trials for Influenza H1N1
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
The record lists no contact. Use the official record to reach the sponsor.
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 H1N1, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
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 2 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 28 Feb 2020. 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 Slovenia. 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?
T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination (time frame: At 3 weeks after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2020.