The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
Public ClinicalTrials.gov record NCT06551506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During the First Year of Life
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children \<5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip \[henceforth referred to as nirsevimab\], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.
Study identification
- NCT ID
- NCT06551506
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 181 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2024
- Primary completion
- May 4, 2026
- Completion
- May 4, 2026
- Last update posted
- May 10, 2026
2024 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30322-1014 | — |
| University of Maryland, School of Medicine, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201-1509 | — |
| New York University School of Medicine - Langone Medical Center - Vaccine Center | New York | New York | 10016-6402 | — |
| University of Rochester Medical Center - Vaccine Research Unit | Rochester | New York | 14611-3201 | — |
| Cincinnati Children's Hospital Medical Center Vaccine Research Center | Cincinnati | Ohio | 45229-3039 | — |
| University of Pittsburgh - Medicine - Infectious Diseases | Pittsburgh | Pennsylvania | 15213-3108 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Baylor College of Medicine | Houston | Texas | 77030-3411 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06551506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06551506 live on ClinicalTrials.gov.