Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age (EPI-ZOSTER-039 VS US DB 214420)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SHINGRIX
• Medical condition to be studied:
  Herpes zoster

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  2844

Study design details

• Main study objective:
  To evaluate the prevalence of major congenital malformations (MCMs) among live births from women with immunocompromised (IC) conditions exposed to HZ/su compared to those not exposed to HZ/su during pregnancy.
• Outcomes:
  Major congenital malformations (MCMs) among live births from women with immunocompromised (IC) conditions exposed to HZ/su compared to those not exposed to HZ/su during pregnancy. ; Additional infant/birth outcomes among live births in women with IC conditions exposed to HZ/su versus those not exposed to HZ/su during pregnancy. ; Pregnancy outcomes and pregnancy complications among livebirth and non-livebirth pregnancies in women with IC conditions exposed to HZ/su versus those not exposed to HZ/su during pregnancy.
• Data analysis plan:
  Annual descriptive analyses to estimate the counts of HZ/su exposed pregnancies among women with IC conditions will be performed. ; Data from the first two years will be used to determine the feasibility of a full-scale cohort study. ; If the feasibility assessment identifies that the number of HZ/su-exposed pregnancies is equal to or above the target number of exposed pregnancies, a subsequent cohort study will be conducted. ; The prevalence of MCMs and additional infant/birth outcomes and their associated 95% CIs will be calculated among women with IC conditions who were exposed to HZ/su during pregnancy versus the corresponding matched women who were not exposed to HZ/su during pregnancy. ; The prevalence of the pregnancy outcomes and pregnancy complications and their 95% CIs will be calculated between the two groups of women. ; All analyses will be stratified by stage of pregnancy (pre-pregnancy, first trimester, second trimester, third trimester).