PREHEVBRIO Pregnancy Outcomes Registry

Launched by VBI VACCINES INC. · Oct 23, 2023

Keywords

ClinConnect Summary

The PREHEVBRIO Pregnancy Outcomes Registry is a study designed to gather information about the effects of the PREHEVBRIO® hepatitis B vaccine on pregnant women and their babies. Researchers want to understand what happens to women who receive this vaccine within 28 days before becoming pregnant or at any point during their pregnancy and delivery. The registry aims to track and analyze reports related to pregnancy and baby health after vaccine exposure, focusing on safety rather than testing new treatments.

To participate in this registry, women need to be pregnant and have received the PREHEVBRIO® vaccine during the specified time frame. They must also agree to share their medical information and allow researchers to contact their healthcare providers for more details. This study is currently recruiting participants, and the information collected will help ensure the safety of the vaccine for future mothers and babies. If you or someone you know might qualify, this could be an important opportunity to contribute to understanding vaccine safety during pregnancy.

Gender

FEMALE

Eligibility 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.