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RECRUITING

PREHEVBRIO Pregnancy Outcomes Registry

NCT06097312 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Data collection

Study Locations (1)

Kansas

  • ProPharma, Recruiting Nationwide — Overland Park

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-11-30
Est. Completion 2032-03-31

Sponsor

VBI Vaccines

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06097312

The ClinicalTrials.gov registry entry for NCT06097312 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VBI Vaccines, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Vaccine Exposure During Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Data collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06097312 reports 1 study location spanning 1 distinct geographic area — top geographies include Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06097312 about?

NCT06097312 is a clinical study titled "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 objectiv...

What is the current status of trial NCT06097312?

This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2023-11-30. Estimated completion is 2032-03-31.

What conditions does trial NCT06097312 study?

This clinical trial studies the following conditions: Vaccine Exposure During Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06097312?

The interventions under investigation include: Data collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06097312?

This trial is sponsored by VBI Vaccines, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06097312 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial