RECRUITING

PREHEVBRIO Pregnancy Outcomes Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective, Observational, Non-interventional Study Designed to Detect and Describe Pregnancy Outcomes in Women Exposed to PREHEVBRIO® [Pregnancy Outcomes Registry]

Quick Facts

Study Start:2023-11-30
Study Completion:2032-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06097312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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).
  3. * 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.
  4. * Reporter's (participant and/or healthcare provider) contact information is available to allow for follow up.
  1. * Subjects participating in another investigational device or drug study product within 28 days prior to conception or at any time during pregnancy.

Contacts and Locations

Study Contact

Project Manager
CONTACT
888-421-8808
medinfo@vbivaccines.com
Francisco Diaz-Mitoma, MD, PhD
CONTACT
613-729-4200
fdiazmitoma@vbivaccines.com

Study Locations (Sites)

ProPharma, Recruiting Nationwide
Overland Park, Kansas, 66210
United States

Collaborators and Investigators

Sponsor: VBI Vaccines Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30
Study Completion Date2032-03-31

Study Record Updates

Study Start Date2023-11-30
Study Completion Date2032-03-31

Terms related to this study

Keywords Provided by Researchers

  • PREHEVBRIO
  • Hepatitis B vaccine
  • Pregnancy

Additional Relevant MeSH Terms

  • Vaccine Exposure During Pregnancy