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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2017-30-11
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
Finalized
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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