The purpose of this post-marketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).
Study Type
OBSERVATIONAL
Enrollment
2,844
This study will be conducted using data provided by U.S. Research Partners in the FDA's Sentinel Surveillance System. Four Research Partners will participate in this study: CVS Health Clinical Trial Services (CTS), Carelon Research, Optum and Harvard Pilgrim Health Care Institute (HPHCI).
GSK Investigational Site
Canton, Massachusetts, United States
Prevalence of Major Congenital Malformations (MCMs)
The prevalence of MCMs among live births from women with immunocompromised conditions exposed to HZ/su vaccine compared to those not exposed to HZ/su vaccine during pregnancy is evaluated. An MCM (birth defect or structural defect) is defined as a defect, which has either cosmetic or functional significance to the child.
Time frame: From birth up to 1 year of age
Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission)
The prevalence of small for gestational age, low birthweight, neonatal intensive care unit admission among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: Within 30 days after the infant's date of birth
Prevalence of additional infant/birth outcome (preterm birth)
The prevalence of the preterm births among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: At birth
Prevalence of additional infant/birth outcome (neonatal death)
The prevalence of the neonatal deaths among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: Within 28 days after birth
Prevalence of pregnancy outcomes (live birth)
The prevalence of the live birth pregnancies among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: At birth
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Prevalence of pregnancy outcomes (stillbirth)
The prevalence of the stillbirth pregnancies among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: At or after 20 weeks' gestation but prior to delivery
Prevalence of pregnancy outcomes (spontaneous abortion)
The prevalence of the spontaneous abortions among all eligible pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: Prior to 20 weeks' gestation
Prevalence of pregnancy complications
The prevalence of pregnancy complications (placental abruption, preeclampsia and eclampsia) among livebirth and non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed.
Time frame: From 20 weeks' gestation through the date of delivery