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RECRUITING
NCT06097312

PREHEVBRIO Pregnancy Outcomes Registry

Sponsor: VBI Vaccines Inc.

View on ClinicalTrials.gov

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.

Official title: Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-11-30

Completion Date

2032-03-31

Last Updated

2023-12-08

Healthy Volunteers

Yes

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).

Locations (1)

ProPharma, Recruiting Nationwide

Overland Park, Kansas, United States