Post-marketing observational surveillance study to evaluate pregnancy outcomes among women who receive Heplisav-B or Engerix-B (DV2-HBV-28)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cluster design

  Cohort

  Other
• Non-interventional study design, other:
  Non-randomised cluster design

Study drug and medical condition

• Name of medicine:
  HEPLISAV B
• Study drug International non-proprietary name (INN) or common name:
  HEPATITIS B SURFACE ANTIGEN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BC01) hepatitis B, purified antigen

  hepatitis B, purified antigen
• Medical condition to be studied:
  Hepatitis B

Population studied

• Age groups:
  Adults (18 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  206