Bayesian Evaluation of Time-To-Event and Reliability (for vaccine surveillance) (BETTER)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Methods research

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Self-controlled case series, Historical rate comparison

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07B) VIRAL VACCINES

  VIRAL VACCINES

Population studied

• Age groups:
  • 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:
  2000000

Study design details

• Main study objective:
  To compare the real-data performance (testing errors, timeliness, precision and bias) of Bayesian and frequentist sequential analysis methods for the study of comparative vaccine safety.
• Data analysis plan:
  Exposures: previous viral vaccines including 2017-2018 flu, H1N1 flu, Human Papillomavirus (HPV), and Varicella-Zoster. Outcomes: selected adverse events of special interest, negative control outcomes, imputed positive control outcomes. Analysis design: self-controlled case series & historical comparator.