Clinical trial NCT02567721: Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
Official title: European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Post-authorisation safety study (PASS)
Adverse Drug Reaction Reporting Systems
Post marketing product surveillance
European Medicines Agency (EMA)
Influenza Vaccine
Computerized Medical Record System
United Kingdom
Primary Health Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University of Surrey
First posted: 2015-10-05
Enrollment: 11530
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015

Brief summary: 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.

Detailed description: Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.

Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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:
measure: Completeness of vaccination data in the computerized medical record system.
timeFrame: Up to 3 months (between 1 September 2015 and 30 November 2015)
measure: Completeness of AEI reporting in the computerized medical record system.
timeFrame: Up to 3 months (between 1 September 2015 and 30 November 2015)
measure: Timeliness of vaccination data in the computerized medical record system.
timeFrame: Up to 3 months (between 1 September 2015 and 30 November 2015)
measure: Timeliness of AEI reporting in the computerized medical record system.
timeFrame: Up to 3 months (between 1 September 2015 and 30 November 2015)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: