Last updated: 03/24/2020 07:30:15

Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: Pilot study in England

GSK study ID
207781
See study documents
Clinicaltrials.gov ID
NCT03278067
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: Pilot study in England 2017/18
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

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:

Occurrence of AEIs reported using data entered in a card-based ADR reporting system and Electronic Health Record (EHR)

Timeframe: Within 7 days post vaccination (Vaccinated period is anticipated to be between 01 September 2017 and 30 November 2017)

Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group

Timeframe: Within 7 days post vaccination

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

Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

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

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

Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status

Timeframe: Within 7 days post vaccination

Interventions:
  • Other: Enhanced vaccine safety surveillance
    • Enrollment:
    23939
    Primary completion date:
    2017-30-11
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    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. 1-10.
    Medical condition
    Influenza, Human
    Product
    GSK2647158A
    Collaborators
    University of Surrey
    Study date(s)
    September 2017 to November 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Surrey, United Kingdom, GU2 7XH
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-30-11
    Actual study completion date
    2017-30-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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