205514 (V72_38OB) - Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive study, Vaccine effectiveness (VE) will be assessed by the screening method, or by a case-control method if the screening method cannot be used (for example, if appropriate coverage data cannot be determined)

Study drug and medical condition

• Name of medicine:
  BEXSERO
• Study drug International non-proprietary name (INN) or common name:
  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN

  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN

  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE

  OUTER MEMBRANE VESICLES FROM NEISSERIA MENINGITIDIS GROUP B (STRAIN NZ 98/254)

  NEISSERIA MENINGITIDIS
• Anatomical Therapeutic Chemical (ATC) code:
  (J07AH09) meningococcus B, multicomponent vaccine

  meningococcus B, multicomponent vaccine

Population studied

• Short description of the study population:
  General population in England.; Individuals were included in the cohorts targeted for vaccination in England.
• Age groups:
  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  The objective of this post-marketing observational study is to assess the impact on MenB and effectiveness of 4CMenB vaccination against MenB disease, after introduction of 4CMenB in the UK
• Outcomes:
  The primary outcome is a capsular group B confirmed case by culture and/or PCR from a normally sterile site (case definition A), regardless of MATS, The secondary outcome is a confirmed or probable case of capsular group B 4CMenB-vaccine-type where protection would have been expected based on the vaccine antigens (case definition B)
• Data analysis plan:
  VE = 1 - (PCV x (1-PPV)) / ((1-PCV) x PPV)VE: Vaccine EffectivenessPCV: Proportion Cases VaccinatedPPV: Proportion Population Vaccinated