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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567721
• Other study ID #: 202055
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: February 11, 2016
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11530
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Completeness of vaccination data in the computerized medical record system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Completeness of AEI reporting in the computerized medical record system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Timeliness of vaccination data in the computerized medical record system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Timeliness of AEI reporting in the computerized medical record system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Completeness of vaccination data in the card-based adverse event reporting system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Completeness of AEI reporting in the card-based adverse event reporting system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Timeliness of vaccination data in the card-based adverse event reporting system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	Timeliness of AEI reporting in the card-based adverse event reporting system.		Up to 3 months (between 1 September 2015 and 30 November 2015)	No
Secondary	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)	No