Herpes Zoster
Conditions
Keywords
Herpes Zoster, Recombinant, Zoster vaccine, Targeted, Safety study, Post-authorization safety study, Pregnant women
Brief summary
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).
Interventions
OTHERData collection
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).
Sponsors
Harvard Pilgrim Health Care Institute
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June 2026. Live births are to be followed for 1 year. * Participant is a female aged 18-49 years on the pregnancy start date. * Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit. * Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored.
Exclusion criteria
* Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations. * Participant delivered an infant identified as having a chromosomal or genetic anomaly. * Ectopic pregnancies, molar pregnancies or induced abortions. * Multigestation (e.g., twin) pregnancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Major Congenital Malformations (MCMs) | From birth up to 1 year of age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of additional infant/birth outcome (preterm birth) | At 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. |
| Prevalence of additional infant/birth outcome (neonatal death) | Within 28 days after birth | 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. |
| Prevalence of pregnancy outcomes (live birth) | At 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. |
| Prevalence of additional infant/birth outcomes (small for gestational age, low birthweight, neonatal intensive care unit admission) | Within 30 days after the infant's date of birth | 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. |
| Prevalence of pregnancy outcomes (spontaneous abortion) | Prior to 20 weeks' gestation | 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. |
| Prevalence of pregnancy complications | From 20 weeks' gestation through the date of delivery | 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. |
| Prevalence of pregnancy outcomes (stillbirth) | At or after 20 weeks' gestation but prior to delivery | 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. |
Countries
United States
Outcome results
None listed