PREHEVBRIO Pregnancy Outcomes Registry
The registry is an observational surveillance program designed to recruit and encourage participation of women who were exposed to PREHEVBRIO® hepatitis B vaccine during pregnancy and to collect and analyze information related to post-exposure pregnancy and fetal and neonatal outcomes. The objective of the Registry is to monitor and evaluate all received reports of PREHEVBRIO® vaccine exposure within 28 days prior to conception or at any time during pregnancy and delivery, as well as maternal, obstetrical, pregnancy, fetal and neonatal outcomes. This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.
Conditions:
🦠 Vaccine Exposure During Pregnancy
🗓️ Study Start (Actual) 30 November 2023
🗓️ Primary Completion (Estimated) 31 March 2032
✅ Study Completion (Estimated) 31 March 2032
👥 Enrollment (Estimated) 120
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Overland Park, Kansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD.
    • * The subject provided consent prior to enrollment (for eligible subjects under 18 years old, consent must be obtained from the subject's legally authorized representative).
    • * The subject documents agreement with the release of medical information and contact with her healthcare providers (e.g., PCP, obstetrician, nurse midwife) and the infant's healthcare provider (e.g., pediatrician) for the purpose of collecting medical information.
    • * Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up.

    Exclusion Criteria:

    • * Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 September 2023
  • First Submitted that Met QC Criteria 23 October 2023
  • First Posted 24 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 November 2023
  • Last Update Posted 8 December 2023
  • Last Verified November 2023