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

NCT01715792 | Completed

• 1 other identifier: 116602
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

Solid organ transplant rejection; United Kingdom; Influenza; H1N1; Pandemrix™

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• 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).

Study Arms (1)

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

Interventions

Data collection OTHER

Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• Subject from HES matched to more than one subject in the CPRD GOLD.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, SW1W 9SZ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26823177 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

GB (1)