Last updated: 06/04/2021 16:20:08

Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero®) vaccination in routine UK care

GSK study ID
205512
See study documents
Clinicaltrials.gov ID
Not applicable
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-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero®) vaccination in routine UK care
Trial description: This observational safety study aims at assessing the safety of 4CMenB vaccination within the UK National Immunisation programme. The study will start in 31st December 2015 (first data cut) and will include data from 1st May 2015 for three years. The study has two stages of analyses one descriptive and one self-controlled case series (SCCS) and uses data from the THIN database an electronic primary care records in the UK. The study outcomes are divided into three primary (All seizures, febrile seizures and Kawasaki disease) and three secondary (acute disseminated encephalomyelitis, Guillain-Barré syndrome and anaphylaxis) outcomes. The first analysis will describe the incidence of each study outcome after vaccination and stage two will apply the SCCS analysis only on the primary outcomes.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Relative incidence of seizures (all and febrile seizures).

Timeframe: 3 year data will be identified from study start (31st December 2015 to approximately December 2018).

Relative incidence of Kawasaki disease.

Timeframe: 3 year data will be identified from study start (31st December 2015 to approximately December 2018).

Secondary outcomes:

Incidence of Acute disseminated encephalomyelitis (ADEM).

Timeframe: 3 year data will be identified from study start (31st December 2015 to approximately December 2018).

Incidence of Guillain-Barré syndrome (GBS) in a descriptive analysis.

Timeframe: 3 year data will be identified from study start (31st December 2015 to approximately December 2018).

Incidence of anaphylaxis in a descriptive analysis.

Timeframe: 3 year data will be identified from study start (31st December 2015 to approximately December 2018).

Interventions:
  • Vaccine: Bexsero
    • Enrollment:
    1
    Primary completion date:
    2018-31-12
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Hall GC, Douglas I, Heath PT, Prabhakar P, Rosillon D, Khan J, Abbing-Karahagopian V. Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero) vaccination within the routine UK immunisation program. Vaccine.S0264-410X(21)00256-5. doi: 10.1016/j.vaccine.2021.02.065.
    Medical condition
    Infections, Meningococcal
    Product
    GSK3536829A
    Collaborators
    Not applicable
    Study date(s)
    December 2015 to December 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    0 Days - 18 Months
    Accepts healthy volunteers
    yes
    • The baseline population includes those children permanently registered at a UK primary care practice which contributes data to The Health Information Network (THIN) database between a start date (1st May 2015) and an end date (approximately December 2018).
    • No exclusion criteria applied to this study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      The baseline population includes those children permanently registered at a UK primary care practice which contributes data to The Health Information Network (THIN) database between a start date (1st May 2015) and an end date (approximately December 2018).

    Exclusion criteria:

      No exclusion criteria applied to this study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2018-31-12
    Actual study completion date
    2018-31-12

    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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