Last updated: 11/03/2018 22:06:57

Post-authorisation safety study (PASS) of influenza vaccine in United Kingdom (UK)

GSK study ID
202055
See study documents
Clinicaltrials.gov ID
NCT02567721
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine
Trial description: The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Secondary outcomes:

Completeness of vaccination data in the computerized medical record system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Completeness of AEI reporting in the computerized medical record system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Timeliness of vaccination data in the computerized medical record system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Timeliness of AEI reporting in the computerized medical record system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Completeness of vaccination data in the card-based adverse event reporting system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Completeness of AEI reporting in the card-based adverse event reporting system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Timeliness of vaccination data in the card-based adverse event reporting system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Timeliness of AEI reporting in the card-based adverse event reporting system.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.

Timeframe: Up to 3 months (between 1 September 2015 and 30 November 2015)

Interventions:
  • Other: Vaccine safety surveillance
    • Enrollment:
    11530
    Primary completion date:
    2015-30-11
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK1536489A, GSK2321138A
    Collaborators
    University of Surrey
    Study date(s)
    October 2015 to November 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6+ years
    Accepts healthy volunteers
    Yes
    • All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
    • Pregnant women are also included in this study.
    • Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
    Inclusion and exclusion criteria
    Inclusion criteria:

      All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.

      • Pregnant women are also included in this study.
    Exclusion criteria:

      Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Surrey, United Kingdom, GU2 7XH
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-30-11
    Actual study completion date
    2015-30-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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