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NCT06551506 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Respiratory Syncytial Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Active
Registry status
Phase 4
Development phase
181
Enrollment target
8
Study locations

NCT06551506 is a Phase 4 study of Respiratory Syncytial Virus Infection that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 181 participants, below the 963-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (81% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT06551506, a Phase 4 study of Respiratory Syncytial Virus Infection, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
181 participants
Enrollment target
8
Study locations

Study Summary

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.

Conditions Studied

Respiratory Syncytial Virus Infection

Interventions

  • BIOLOGICAL Abrysvo
  • BIOLOGICAL Beyfortus

Study Locations (8)

New York

  • New York University School of Medicine - Langone Medical Center - Vaccine Center - New York
  • University of Rochester Medical Center - Vaccine Research Unit - Rochester

Georgia

  • Emory University School of Medicine - Atlanta

Maryland

  • University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore

Ohio

  • Cincinnati Children's Hospital Medical Center Vaccine Research Center - Cincinnati

Pennsylvania

  • University of Pittsburgh - Medicine - Infectious Diseases - Pittsburgh

Tennessee

  • Vanderbilt University Medical Center - Nashville

Texas

  • Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2024-09-19
Est. Completion 2026-05-31
Phase Phase 4

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06551506

The ClinicalTrials.gov registry entry for NCT06551506 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 963-participant average among 4 other Respiratory Syncytial Virus Infection trials with a reported enrollment target (81% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Respiratory Syncytial Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Abrysvo is the first listed.

NCT06551506 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New York, Georgia, Maryland.

Frequently Asked Questions

What is clinical trial NCT06551506 about?

NCT06551506 is a clinical study titled "The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products". 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 t...

What is the current status of trial NCT06551506?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2024-09-19. Estimated completion is 2026-05-31.

What conditions does trial NCT06551506 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus Infection.

What interventions are being tested in trial NCT06551506?

The interventions under investigation include: Abrysvo (BIOLOGICAL), Beyfortus (BIOLOGICAL).

Who is sponsoring clinical trial NCT06551506?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06551506 being conducted?

This trial has 8 study locations across Georgia, Maryland, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.