NCT02567721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

September 18, 2015

Last Update Submit

February 11, 2016

Conditions

Influenza

Keywords

Post-authorisation safety study (PASS)Adverse Drug Reaction Reporting SystemsPost marketing product surveillanceEuropean Medicines Agency (EMA)Influenza VaccineComputerized Medical Record SystemUnited KingdomPrimary Health Care

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (9)

  • 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)

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

Vaccine safety surveillanceOTHER

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.

Also known as: Data collection
Study Cohort

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 5, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

GB(1)