Last updated: 06/26/2019 10:50:17
Assess the risk of solid organ transplant rejection following vaccination with Pandemrix™ in UK
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Risk of solid organ transplant rejection following vaccination with Pandemrix™ in the United Kingdom
Trial description: This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Timeframe: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
Secondary outcomes:
Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
Timeframe: Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).
Interventions:
Other: Data collection
Enrollment:
587
Observational study model:
Other
Primary completion date:
2013-07-08
Time perspective:
Retrospective
Clinical publications:
Cohet C et al. (2016) 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. 6(1):e009264.
Dos Santos G et al. (2017) Adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccines and solid organ transplant rejection: systematic signal evaluation and lessons learnt. Drug Saf. doi: 10.1007/s40264-017-0532-3.
Medical condition
Influenza
Product
GSK2340274A, GSK2647158A
Collaborators
Not applicable
Study date(s)
October 2012 to August 2013
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- 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).
- Subject from HES matched to more than one subject in the CPRD GOLD.
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
Subject defined as acceptable in the CPRD GOLD.
Exclusion criteria:
Subject from HES matched to more than one subject in the CPRD GOLD.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2013-07-08
Actual study completion date
2013-07-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website