DARWIN EU® - Coverage of meningococcal vaccines in the target population in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Monovalent Meningococcal group B surface protein vaccine, Monovalent Meningococcal group B surface protein vaccine, Quadrivalent Meningococcal conjugate vaccine (groups A, C, W-135, and Y)

Population studied

• Short description of the study population:
  This study will include all individuals present in their respective database who reach two years of age for examining the coverage of MenB or Hib/MenC vaccines, and 18 years of age for examining the coverage of MCV4 vaccines
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A drug utilisation cohort study will be conducted, using routinely collected health data from seven nationwide or regional databases in six European countries
• Main study objective:
  1. To examine the coverage of MenB vaccines in children at age one and two years by dose received (≥1 dose, ≥2 doses, ≥3 doses, =1 dose, =2 doses, =3 doses); 2. To examine the coverage of MenC or Hib/MenC conjugate vaccines in children at age two years (≥1 dose, =1 dose); 3. To examine the coverage of MCV4 vaccines in individuals at age 18 years (≥1 dose, =1 dose); 4. To estimate the coverage of specific brand of MenB vaccines (Bexsero® and Trumemba®) in individuals aged two years and MCV4 vaccines (Menveo® and Nimenrix®) in individuals aged 18 years = ; 5. To characterise the age distribution of receival of MenB, MenC, and MCV4 vaccines;
• Data analysis plan:
  The point prevalence of recipients of vaccine coverage at quarterly and yearly time interval were estimated; using the IncidencePrevalence package. The age distribution of vaccine recipients was characterised using; the CohortCharacteristics package in R. Missing records for a given variable or outcome were assumed to indicate that the information was not present, or that a given individual was unvaccinated. Sensitivity analyses were conducted by 1) defining the study population as the target population for specific meningococcal vaccines without the requirement for complete follow-up and 2) defining the study population for the coverage of MCV4 as all individuals aged between 12 and 18 to test for the robustness of the findings and to examine the coverage of MCV4 in a broader population. A minimum cell count of 5 will be used when reporting results, with any smaller count reported as “<5” and zero counts as “0”.