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PREHEVBRIO Pregnancy Outcomes Registry

NCT06097312 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-05-11

No results posted yet for this study

Summary

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

Interventions

OTHER

Data collection

The schedule of office visits and all treatment regimens will be determined by the treating health care provider. No interventions are administered as part of this protocol (observational study).

Sponsors & Collaborators

  • VBI Vaccines Inc.

    lead INDUSTRY

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2032-03-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097312 on ClinicalTrials.gov