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

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, 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;