← Back to Search

Participants for Vaccine Exposure During Pregnancy

N/A
Recruiting
Research Sponsored by VBI Vaccines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from gestation until termination of pregnancy, up to 10 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from gestation until termination of pregnancy, up to 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from gestation until termination of pregnancy, up to 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of major congenital malformations
Rate of spontaneous abortion
Secondary outcome measures
Rate of ectopic pregnancy
Rate of fetal death/stillbirth
Rate of induced abortion
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
Pregnant women who received PREHEVBRIO® vaccine within 28 days prior to conception or at any time during pregnancy.

Find a Location

Who is running the clinical trial?

VBI Vaccines Inc.Lead Sponsor
11 Previous Clinical Trials
5,572 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PREHEVBRIO Pregnancy Outcomes Registry
2023. "PREHEVBRIO Pregnancy Outcomes Registry". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06097312.
All > Kansas City
~80 spots leftby Mar 2032
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top