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Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

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ClinicalTrials.gov Identifier: NCT03278067
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

Condition or disease Intervention/treatment
Influenza, Human Other: Enhanced vaccine safety surveillance

Detailed Description:
This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.

Study Type : Observational
Actual Enrollment : 27006 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Study cohort
Volunteered subjects who will receive influenza vaccination in approximately10 practices.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other Name: Data collection




Primary Outcome Measures :
  1. Occurrence of AEIs reported using a card-based ADR reporting system [ Time Frame: Within 7 days post vaccination (Vaccinated period is anticipated to be between 01 September 2017 and 30 November 2017). ]
    AEI data will be presented overall, by brand (Fluarix Tetra vs. others), by age strata, and UK Chief Medical Officer (CMO)-specified risk groups status (at risk/not at risk) by system organ categories.


Secondary Outcome Measures :
  1. Occurrence of AEIs reported using data entered in a card-based ADR reporting system and Electronic Health Record (EHR) [ Time Frame: Within 7 days post vaccination (Vaccinated period is anticipated to be between 01 September 2017 and 30 November 2017) ]

    AEI data will be presented by system organ categories, by brand (Fluarix Tetra vs. others), by age strata, and UK Chief Medical Officer (CMO)-specified risk groups status (at risk/not at risk).

    This data will be reported on a weekly basis with a cumulative analysis for the entire vaccination period.



Biospecimen Retention:   None Retained
Not applicable (no sample)


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Registered patients in up to 10 general practices in UK immunized against seasonal influenza at the beginning of 2017/18 season.
Criteria

Inclusion Criteria:

  • All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278067


Locations
United Kingdom
GSK Investigational Site
Surrey, United Kingdom, GU2 7XH
Sponsors and Collaborators
GlaxoSmithKline
University of Surrey
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03278067     History of Changes
Other Study ID Numbers: 207781
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
England
Adverse Event of Interest
Seasonal influenza vaccines
Pilot study
Prospective passive enhanced safety surveillance

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs