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

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Primary Purpose

Status

Completed

Phase

Locations

United Kingdom

Study Type

Observational

Intervention

Vaccine safety surveillance

About this trial

This is an observational trial for Influenza focused on measuring 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

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Arm Label

Study Cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

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

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)

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

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.

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.

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.

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.

Secondary Outcome Measures

Completeness of vaccination data in the computerized medical record system.

Completeness of AEI reporting in the computerized medical record system.

Timeliness of vaccination data in the computerized medical record system.

Timeliness of AEI reporting in the computerized medical record system.

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

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

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

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

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.

Full Information

NCT ID

NCT02567721

First Posted

September 18, 2015

Last Updated

February 11, 2016

Sponsor

GlaxoSmithKline

Collaborators

University of Surrey

1. Study Identification

Unique Protocol Identification Number

NCT02567721

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

University of Surrey

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Enrollment

11530 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Cohort

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Vaccine safety surveillance

Other Intervention Name(s)

Data collection

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Time Frame