Influenza Clinical Trial
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.
Status | Completed |
Enrollment | 587 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | GSK Investigational Site | London |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010). | No |
Secondary | 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. | Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010). | No |
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