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The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products

Trial to study RSV vaccine and immunization safety for moms and babies.

Recruiting
18-45 years
Female
Phase 4

This study is about checking the safety and effectiveness of two new tools to protect babies from a virus called RSV (Respiratory Syncytial Virus). RSV can cause serious lung infections in young children. The FDA (Food and Drug Administration) has approved two ways to prevent RSV: a vaccine called ABRYSVO given to pregnant women, and a medicine called BEYFORTUS given to newborns. This study will see how well these methods work to keep babies safe from RSV for up to 12 months. We will also study if using both products together is better than using just one. Women aged 18-45 with a healthy pregnancy can join this study. They should agree to follow study rules and deliver in a place where study procedures are possible. The study will help us understand if using both products is safe and beneficial.

  • Study Duration: The study will follow infants for 12 months.
  • Eligibility: Pregnant women aged 18-45 with no major complications.
  • Safety: Monitoring for any side effects from the vaccine or medicine.
Study details
    Respiratory Syncytial Virus Infection

NCT06551506

National Institute of Allergy and Infectious Diseases (NIAID)

16 March 2025

Step 1 Get in touch with the nearest study center
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