Registry for pregnancy outcomes after hepatitis B vaccination
Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]
This study is collecting information from pregnant women who received the hepatitis B vaccine to see how it affects their health and their babies' health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | Female |
| Sponsor | VBI Vaccines Inc. Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06097312 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect and analyze data from women who received the PREHEVBRIO® hepatitis B vaccine during pregnancy or within 28 days prior to conception. The study focuses on monitoring maternal, obstetrical, pregnancy, fetal, and neonatal outcomes to evaluate potential safety signals associated with the vaccine. By gathering real-world data, the registry seeks to provide insights into the safety of PREHEVBRIO® in pregnant women, a group that was excluded from clinical trials during its development. The information collected will help inform future recommendations regarding hepatitis B vaccination in pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this registry are pregnant women who have received the PREHEVBRIO® vaccine within 28 days prior to conception or at any time during their pregnancy.
Not a fit: Patients who have not been exposed to the PREHEVBRIO® vaccine during pregnancy will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide critical safety data that may lead to informed guidelines for hepatitis B vaccination in pregnant women.
How similar studies have performed: While this registry approach is observational and primarily descriptive, similar studies have successfully gathered safety data for other vaccines during pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant woman who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy. The time of conception will be calculated as the most reliable estimated date of delivery (EDD) minus 38 weeks. For this registry, gestational weeks will be estimated from the EDD or as corrected EDD, if a more reliable EDD (e.g., by ultrasound) is provided. If the EDD is not available or never estimated, the first day of the last menstrual period (LMP) will be used to estimate gestational age and EDD. * 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: * Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.
Where this trial is running
Overland Park, Kansas
- ProPharma, Recruiting Nationwide — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Project Manager
- Email: medinfo@vbivaccines.com
- Phone: 888-421-8808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.