Clinical trial NCT01715792: Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
Official title: Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Solid organ transplant rejection
United Kingdom
Influenza
H1N1
Pandemrix™
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 587
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: 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).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.