Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)

European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Other: Vaccine safety surveillance

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.

• Study Type: Observational
• Enrollment (Actual): 11530

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey, United Kingdom, GU2 7XH
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Cohort; Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted.	Other: Vaccine safety surveillance; Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.; Other Names: Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)		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)		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)		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)		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)	- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.	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)	- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.	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)	- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.	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)	- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.	Up to 3 months (between 1 September 2015 and 30 November 2015)

Secondary Outcome Measures

Outcome Measure	Time Frame
Completeness of vaccination data in the computerized medical record system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the computerized medical record system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the computerized medical record system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the computerized medical record system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of vaccination data in the card-based adverse event reporting system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Completeness of AEI reporting in the card-based adverse event reporting system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of vaccination data in the card-based adverse event reporting system.	Up to 3 months (between 1 September 2015 and 30 November 2015)
Timeliness of AEI reporting in the card-based adverse event reporting system.	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.	Up to 3 months (between 1 September 2015 and 30 November 2015)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: University of Surrey

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Primary Health Care; Influenza Vaccine; United Kingdom; Post-authorisation safety study (PASS); Adverse Drug Reaction Reporting Systems; Post marketing product surveillance; European Medicines Agency (EMA); Computerized Medical Record System
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 202055