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Completed

NCT Number: NCT02567721

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Surrey, GU2 7XH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaccine safety surveillance

Other

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

Primary outcomes

  1. 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: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  3. 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)

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  5. 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)

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

    • 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.

  6. 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)

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

    • 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.

  7. 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)

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

    • 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.

  8. 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)

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

    • 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 outcomes

  1. Completeness of vaccination data in the computerized medical record system.

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  2. Completeness of AEI reporting in the computerized medical record system.

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  3. Timeliness of vaccination data in the computerized medical record system.

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  4. Timeliness of AEI reporting in the computerized medical record system.

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

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

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

  9. 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.

    Time frame: Up to 3 months (between 1 September 2015 and 30 November 2015)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2015
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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