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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2015-30-11
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
Finalized
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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