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
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2018-31-12
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
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Location
GSK Investigational Site
London, United Kingdom
Status
Study Complete
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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
Finalized
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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