Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01715792
First received: October 25, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.


Condition Intervention
Influenza
Other: Data collection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 587
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Other: Data collection
Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715792

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, SW1W 9SZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01715792     History of Changes
Other Study ID Numbers: 116602
Study First Received: October 25, 2012
Last Updated: February 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Solid organ transplant rejection
United Kingdom
Influenza
H1N1
Pandemrix™

ClinicalTrials.gov processed this record on September 29, 2014