Clinical trial NCT03278067: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Official title: Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: England
Adverse Event of Interest
Seasonal influenza vaccines
Pilot study
Prospective passive enhanced safety surveillance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: University of Surrey
First posted: 2017-09-11
Enrollment: 23939
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
Secondary outcomes:
measure: Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
measure: Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
timeFrame: Within 7 days post vaccination
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: de Lusignan S, Damaso S, Ferreira F, Byford R, McGee C, Pathirannehelage S, Shende V, Yonova I, Schmidt A, Schuind A, Dos Santos G. Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. Hum Vaccin Immunother. 2020 Aug 2;16(8):1762-1771. doi: 10.1080/21645515.2019.1705112. Epub 2020 Mar 2.