NCT05811754进行中（未招募）不适用
Post-marketing Commitment Safety Study of HZ/su to Evaluate Pregnancy Exposures and Outcomes in Immunodeficient or Immunosuppressed Women Between 18 and 49 Years of Age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,844
- 试验地点
- 1
- 主要终点
- Prevalence of Major Congenital Malformations (MCMs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant who is pregnant with a pregnancy start date between 01 July 2021 and 30 June
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of Major Congenital Malformations (MCMs)
时间窗: 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.
次要结局
- 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)
- Prevalence of additional infant/birth outcome (preterm birth)(At birth)
- Prevalence of additional infant/birth outcome (neonatal death)(Within 28 days after birth)
- Prevalence of pregnancy outcomes (live birth)(At birth)
- Prevalence of pregnancy outcomes (stillbirth)(At or after 20 weeks' gestation but prior to delivery)
- Prevalence of pregnancy outcomes (spontaneous abortion)(Prior to 20 weeks' gestation)
- Prevalence of pregnancy complications(From 20 weeks' gestation through the date of delivery)
研究者
研究点 (1)
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