HEPLISAV-B® Pregnancy Registry: an observational study on the safety of HEPLISAV-B exposure in pregnant women and their offspring (DV2-HBV-27)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study of pregnant women who received dose of HEPLISAV-B vaccine within 28 days prior to conception or any time during pregnancy. Registry will collect data routinely documented in medical records in the course of usual care

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 virus test

  Congenital anomaly
• Additional medical condition(s):
  Major congenital malformations (MCMs) is defined as any major structural or chromosomal defect or combination of two or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age (including outcomes prior to 20 weeks’ gestation or birth weight <,500 g).

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The objective of the HEPLISAV-B® Pregnancy Registry is to evaluate pregnancy outcomes among women who received a dose of the HEPLISAV-B vaccine within 28 days prior to conception or at any time during pregnancy. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.
• Outcomes:
  Rate of Major Congenital Malformations in Live-Born Infants Time Frame: Live-born infants will be followed to 12 months of age, Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age Time Frame: Follow-up will end at the time of pregnancy outcome up to 9 months, Preterm birth (an infant born at gestational age < 37 weeks), Stillbirth (a fetal death occurring at 20 weeks’ gestation or greater, or, if gestational age is unknown, a fetus weighing 500 g or more), Spontaneous abortion (SAB) (fetal death or expulsion of products of conception prior to 20 weeks’ gestation. Terminology may include missed abortion, incomplete abortion, and inevitable abortion)
• Data analysis plan:
  This study is observational, and epidemiological methods will be employed for data collection and analyses. In general, statistical analyses will be descriptive in nature and will be conducted by data analysts in accordance with the study objectives, statistical analysis plan (SAP), table/listing shells referenced herein, and applicable guidelines. No formal comparisons are planned, and no hypotheses will be formally tested. For each continuous variable, the number of observations, median, mean, standard deviation, minimum, and maximum will be provided. For each categorical variable, the frequency and percentage in each category will be provided. Results will be rounded to 1 decimal place, therefore, percentages may not always add up to 100. The use of statistical tests will be limited (given the descriptive nature of the study), favoring instead 95% confidence intervals to reflect uncertainty. Data will be summarized in tables and listings as appropriate.