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Clesrovimab for Respiratory Syncytial Virus

CR
Overseen ByChristina Rostad, MD
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Clesrovimab is an FDA-approved antibody drug recommended for infants younger than 8 months who are entering their first respiratory syncytial virus (RSV) season and whose mothers did not receive an RSV vaccine during pregnancy. It is given to help prevent severe RSV illness. This study will measure clesrovimab and other RSV antibodies in infants' blood and noses to learn how much of the drug reaches the nose, how long the antibodies remain, and how antibody levels change if an infant becomes infected with RSV.

Who Is on the Research Team?

CR

Christina Rostad, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for babies younger than 8 months old who are about to go through their first RSV season and whose mothers did not get an RSV vaccine during pregnancy.

Inclusion Criteria

My parent or guardian can understand and follow the study requirements.
Subject available to complete approximately 6 months follow-up period after receipt of study drug
My baby is under 8 months old and in their first respiratory season.
See 3 more

Exclusion Criteria

Maternal receipt of RSV vaccine during pregnancy with infant participant
I have not had a fever or acute illness in the past 3 days.
I have received or plan to receive polyclonal antibodies or plasma during the study.
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Clesrovimab

Trial Overview

The study is testing clesrovimab, a medicine given as an antibody shot to help prevent severe RSV illness in infants. Researchers will measure how much of the drug and other antibodies are present in the blood and nose over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Infants Receiving Clesrovimab (Enflonsia™)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
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Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

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Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

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