InfluenzaNCT01715792
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
An observational study of Influenza, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- Data collection
- How many people
- 587 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Aug 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study periods (01 September 2006 to 31 October 2010).
Who may be able to join
- Subject defined as acceptable in the CPRD GOLD.
- Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).
Who cannot join
- Subject from HES matched to more than one subject in the CPRD GOLD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Read the detailed description
Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In addition, studies have shown that influenza infection is a known independent risk factors for rejection. Considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.
Using the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza vaccination and of various infections including influenza H1N1 will also be explored.
- Conditions
- Influenza
- Being tested
- Data collection
- Keywords
- Solid organ transplant rejection, United Kingdom, Influenza, H1N1, Pandemrix™
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010). Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
Measured: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
Secondary outcomes (1)
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
Measured: Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
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 InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Time perspective
- Retrospective
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715792
- Sponsor's protocol ID
- 116602
- Status last verified
- Feb 2014
- First submitted
- 25 Oct 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
Publications
Cohet C, Haguinet F, Dos Santos G, Webb D, Logie J, Lc Ferreira G, Rosillon D, Shinde V. Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series. BMJ Open. 2016 Jan 28;6(1):e009264. doi: 10.1136/bmjopen-2015-009264.
PubMed 26823177
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
- ClinicalTrials.gov ID
- NCT01715792
- Acronym / sponsor ID
- 116602
- Conditions
- Influenza
- Keywords
- Solid organ transplant rejection, United Kingdom, Influenza, H1N1, Pandemrix™
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Oct 2012 (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 study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Detailed description
Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In addition, studies have shown that influenza infection is a known independent risk factors for rejection. Considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population.
Using the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza vaccination and of various infections including influenza H1N1 will also be explored.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Data collectionSubject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study periods (01 September 2006 to 31 October 2010).
Key inclusion criteria (2 listed)
- Subject defined as acceptable in the CPRD GOLD.
- Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).
Key exclusion criteria (1 listed)
- Subject from HES matched to more than one subject in the CPRD GOLD.
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 |
|---|---|---|
| Data collectionData extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire. | Other | Group 1 |
Primary outcome
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Time frame: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
1 secondary outcome
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Time frame: Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 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 10 Feb 2014.
- Derived from this study: PubMed 26823177Cohet C, Haguinet F, Dos Santos G, Webb D, Logie J, Lc Ferreira G, Rosillon D, Shinde V. Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series. BMJ Open. 2016 Jan 28;6(1):e009264. doi: 10.1136/bmjopen-2015-009264.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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, run by GlaxoSmithKline at 1 site in United Kingdom.
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 10 Feb 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 United Kingdom. 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?
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas). (time frame: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 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 NCT01715792, 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 10 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.