Organ TransplantationNCT01256931
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
An observational study of Organ Transplantation, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study. The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Organ Transplantation
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2010to not given
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transplant patients at the out-patient clinical ward and staff members of the Transplant Institute, Sahlgrenska University Hospital
Who may be able to join
None listed.
Who cannot join
- Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
Marie Felldin, MD, +46 31 342 10 00, marie.felldin@vgregion.se
About this study
Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study.
The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.
Read the detailed description
Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study.
Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined.
The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.
- Conditions
- Organ Transplantation
- Keywords
- 2009 H1N1 influenza vaccine, organ transplant patients,, booster with Fluarix
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 |
|---|---|---|
| organ transplant patients | Not described | |
| healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
Measured: 4 months
Secondary outcomes (1)
Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination
Measured: February 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
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 Organ TransplantationStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vanda Friman, MD, Ph.D, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256931
- Sponsor's protocol ID
- MMV-305
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2010
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Felldin M, Andersson B, Studahl M, Svennerholm B, Friman V. Antibody persistence 1 year after pandemic H1N1 2009 influenza vaccination and immunogenicity of subsequent seasonal influenza vaccine among adult organ transplant patients. Transpl Int. 2014 Feb;27(2):197-203. doi: 10.1111/tri.12237. Epub 2013 Dec 2.
PubMed 24289658
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
- ClinicalTrials.gov ID
- NCT01256931
- Acronym / sponsor ID
- MMV-305
- Conditions
- Organ Transplantation
- Keywords
- 2009 H1N1 influenza vaccine, organ transplant patients,, booster with Fluarix
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- First posted
- 9 Dec 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.
Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study.
The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.
Detailed description
Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study.
Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined.
The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| organ transplant patients | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transplant patients at the out-patient clinical ward and staff members of the Transplant Institute, Sahlgrenska University Hospital
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.
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
Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
Time frame: 4 months
1 secondary outcome
Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination
Time frame: February 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
- Derived from this study: PubMed 24289658Felldin M, Andersson B, Studahl M, Svennerholm B, Friman V. Antibody persistence 1 year after pandemic H1N1 2009 influenza vaccination and immunogenicity of subsequent seasonal influenza vaccine among adult organ transplant patients. Transpl Int. 2014 Feb;27(2):197-203. doi: 10.1111/tri.12237. Epub 2013 Dec 2.
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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.
Vanda Friman, MD, Ph.D principal investigator
Sahlgrenska University Hospital
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 Organ Transplantation, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 0 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: status not confirmed, as of the sponsor's last update on 9 Dec 2010. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Felldin, MD (+46 31342 10 00, marie.felldin@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls (time frame: 4 months). 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 NCT01256931, 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 9 Dec 2010.