Effectiveness evaluation of the local additional risk minimisation measures for STAMARIL® in the United Kingdom: a survey for healthcare professionals and vaccinees

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Medicinal product name, other:
  STAMARIL; Stamaril Pasteur; Live attenuated yellow fever virus;
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BL) Yellow fever vaccines

  Yellow fever vaccines

  (J07BL01) yellow fever, live attenuated

  yellow fever, live attenuated
• Medical condition to be studied:
  Yellow fever

Population studied

• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To measure awareness and utilisation of any standardized UK yellow fever pre-vaccination checklist(s), evaluate knowledge and understanding of the key safety messages in checklist(s), among qualified HCPs of designated authorised YFVCs in UK.; To measure distribution of the STAMARIL® PIL by qualified HCPs of designated authorised YFVCs and verify the receipt of the PIL by yellow fever vaccinees.
• Outcomes:
  Awareness of the UK (STAMARIL®) yellow fever pre-vaccination checklist Utilisation of any standardised yellow fever pre-vaccination checklist(s) Distribution of the STAMARIL® PIL by qualified HCPs to vaccinees Knowledge and understanding of the key safety messages Receipt of the STAMARIL® PIL.
• Data analysis plan:
  The statistical analysis will be conducted using the SAS® software V9.4 (SAS Institute North Carolina, USA), or R version 3.6 or higher on Windows™. All the analyses will be descriptive. Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, and median, Q1, Q3, minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. The proportions of respondents who provide correct answers to each question will be calculated. Confidence intervals of 95% will be calculated when relevant.