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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41061
• EU PAS number:
  EUPAS11728
• Study ID:
  41061
• Official title and acronym:
  Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero®) vaccination in routine UK care
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The objective is to assess the safety of 4CMenB vaccination within the UK National Immunisation program (NIP). The study design is an observational descriptive study followed by a comparative self-controlled case series (SCCS) for primary outcomes based on THIN database of UK primary care records. The primary outcomes are seizures (all and febrileseizures), and Kawasaki disease. Acute disseminated encephalomyelitis (ADEM), Guillain-Barré syndrome (GBS), and anaphylaxis are secondary outcomes. The exposure of interest is meningococcal B vaccine 4CMenB (Bexsero®). The incidence of each outcome will be estimated during an outcome specific post-exposure risk period. The incidence after any immunisation dose in total and after each immunization dose (recommended as 2, 4 and 12-13 months) will be estimated. The risk period is the time frame when an outcome might be expected to occur if it was caused by the exposure based on known mechanisms, published studies or case reports. A plot will be produced to show the temporal distribution of episodes of outcomes around the date of the exposure.Relative incidence and 95% confidence intervals will be estimated using the self-controlled case series (SCCS) method. Within the SCCS, person time and outcomes for each individual will be assigned to the outcome specific post-exposure risk period or a control period outside this time. A relative incidence will then be calculated.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gillian Hall

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 11/11/2014

Actual: 02/11/2011

Study start date

Planned: 31/12/2015

Actual: 08/12/2015

Date of interim report, if expected

Planned: 31/12/2017

Actual: 30/01/2018

Date of final study report

Planned: 12/06/2020

Actual: 12/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK Vaccines s.r.l.

Study protocol

Initial protocol

V72_36OB-04 Trial Registration Form-ENCePP Registration-2015-08-24-76747267

Updated protocol

V72_36OB-04 Revised Protocol-v3-2015-11-13-77293343 pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)