Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-11-30
2032-03-31
Brief Summary
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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.
Detailed Description
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According to the American College of Obstetricians and Gynecologists, pregnant women who are negative for hepatitis B virus infection and who are at risk for hepatitis B virus infection should be specifically targeted for hepatitis B vaccination. However, more data is required to make such a recommendation for PREHEVBRIO®. The rationale to conduct this study, include: (1) PREHEVBRIO®, as a newly licensed vaccine in the U.S., is not indicated for pregnant women; (2) pregnant women were actively excluded from trials during clinical development of PREHEVBRIO®; and (3) there have only been limited human data to inform the safety of PREHEVBRIO® administered during pregnancy. Since PREHEVBRIO® vaccination is not indicated in pregnancy, exposure to PREHEVBRIO® in pregnancy is likely to be inadvertent and to occur in early pregnancy.
The purpose of the registry is to detect, describe, and evaluate adverse pregnancy outcomes in females exposed to PREHEVBRIO® within 28 days prior to conception or at any time during pregnancy and to detect adverse fetal and/or neonatal outcomes at delivery or early termination.
The registry is strictly observational; schedule of office visits and all treatment regimens will be determined by the treating health care provider; no additional laboratory tests or assessments are required as part of this registry; only data noted as part of routine care will be collected. Subjects will be followed from enrollment until 3 months post-delivery or early termination of pregnancy.
Pregnant women will be enrolled in the registry prospectively (after exposure to the product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports. The analyses of study data will primarily use descriptive and inferential statistical methods designed to detect potential safety signals, rather than test hypotheses.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Pregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
Yes
Sponsors
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VBI Vaccines Inc.
INDUSTRY
Responsible Party
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Locations
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ProPharma, Recruiting Nationwide
Overland Park, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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PREHEVBRIO-REGISTRY-US
Identifier Type: -
Identifier Source: org_study_id