RSV Vaccine Pregnancy Registry

Launched by COREVITAS · Jul 23, 2024

Keywords

ClinConnect Summary

The RSV Vaccine Pregnancy Registry is a clinical trial designed to understand the safety of the Respiratory Syncytial Virus (RSV) vaccine when given to pregnant women between 32 and 36 weeks of pregnancy. The study aims to find out if the vaccine might lead to any problems during pregnancy, such as preterm birth or high blood pressure issues in mothers. Researchers are also interested in other outcomes, like stillbirth, cesarean delivery, and the health of newborns, including their weight and need for special care in the hospital.

To participate in this study, women must be between 18 and 50 years old, living in the U.S., and at least 32 weeks pregnant when they enroll. They should have received the RSV vaccine during the specified time window. Participants will provide consent for their healthcare providers to share their health information with the study team. If eligible, participants can expect to be part of a registry that tracks any health outcomes for both mothers and babies related to the vaccine. This study is important in ensuring the safety of RSV vaccination for pregnant women and their infants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:
• • 1. A resident of the US at enrollment
• • 2. 18 to 50 years of age at enrollment
• • 3. Gestational age of ≥32 weeks, 0 days at enrollment
• • 4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
• • 5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• • 6. Authorization obtained for the relevant HCP(s) to provide data to the registry
• • 7. Contact information available (for participant and HCPs)
• Exclusion Criteria:
• * Individuals meeting any of the following criteria will not be included in the study:
• • 1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation
• • 2. Multi-fetal pregnancy
• • 3. Enrolled in the RSV-PR with a previous pregnancy