Influenza
Conditions
Keywords
Solid organ transplant rejection, United Kingdom, Influenza, H1N1, Pandemrix™
Brief summary
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.
Interventions
OTHERData collection
Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
Sponsors
GlaxoSmithKline
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
• Subject from HES matched to more than one subject in the CPRD GOLD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas). | Within two months 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. |
Countries
United Kingdom
Outcome results
None listed