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NCT06097312 · ClinicalTrials.gov registry record
PREHEVBRIO Pregnancy Outcomes Registry
A clinical trial of Vaccine Exposure During Pregnancy, sponsored by VBI Vaccines.
- Recruiting
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT06097312 is a study of Vaccine Exposure During Pregnancy that is actively recruiting participants, run by VBI Vaccines. The registered enrollment target is 120 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06097312, a study of Vaccine Exposure During Pregnancy, is actively recruiting participants, sponsored by VBI Vaccines.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Data collection
Study Locations (1)
Kansas
- ProPharma, Recruiting Nationwide - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2032-03-31 |
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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, categorized as an unspecified phase. 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 4 total studies on file at ClinicalTrials.gov.
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.
NCT06097312 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
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.
What interventions are being tested in trial NCT06097312?
The interventions under investigation include: Data collection (OTHER).
Who is sponsoring clinical trial NCT06097312?
This trial is sponsored by VBI Vaccines, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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