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Clesrovimab for Prevention of RSV Disease in Healthy Infants

by Railkar, Radha A. , Ikeda, Kazushige , Lutkiewicz, Jeannine , Senders, Shelly D. , Dionne, Marc , Simões, Eric A.F. , Shepard, Julie S. , Liu, Enmei , Laoprasopwattana, Kamolwish , Novoa, Jose M. , Jackowska, Teresa , Maas, Brian M. , Vora, Kalpit A. , Guerra, Andrea , Vargas, Sergio L. , Lee, Andrew W. , Zar, Heather J. , Piedrahita, Jorge , Sinha, Anushua , Ishihara, Yasunori , Ramilo, Octavio , Zhang, Ying , Madhi, Shabir A. , Zang, Xiaowei

in Antibodies, Monoclonal, Humanized - administration & dosage / Antibodies, Monoclonal, Humanized - adverse effects / Antiviral Agents - administration & dosage / Antiviral Agents - adverse effects / Babies / Childhood Diseases / Confidence intervals / Disease prevention / Double-Blind Method / Drugs, Investigational - administration & dosage / Drugs, Investigational - adverse effects / Female / Follow-Up Studies / Fusion protein / Gestational age / Global Health / Hospitalization / Hospitalization - statistics & numerical data / Humans / Hypotheses / Incidence / Infant / Infant, Newborn / Infant, Premature / Infants / Infections / Infectious Disease / Infectious Disease General / Injections, Intramuscular / Male / Monoclonal antibodies / Pediatrics / Pediatrics General / Pharmacokinetics / Placebos / Respiratory syncytial virus / Respiratory Syncytial Virus Infections - diagnosis / Respiratory Syncytial Virus Infections - epidemiology / Respiratory Syncytial Virus Infections - prevention & control / Respiratory Syncytial Virus Infections - virology / Respiratory Syncytial Virus, Human - immunology / Respiratory Syncytial Virus, Human - isolation & purification / Respiratory tract infection / Respiratory Tract Infections - epidemiology / Respiratory Tract Infections - prevention & control / Severity of Illness Index / Surveillance / Viral Fusion Proteins - immunology / Viral Infections

2025

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2025

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2025

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Journal Article

Clesrovimab for Prevention of RSV Disease in Healthy Infants

Railkar, Radha A.,

Ikeda, Kazushige,

Lutkiewicz, Jeannine,

Senders, Shelly D.,

Dionne, Marc,

Simões, Eric A.F.,

Shepard, Julie S.,

Liu, Enmei,

Laoprasopwattana, Kamolwish,

Novoa, Jose M.,

Jackowska, Teresa,

Maas, Brian M.,

Vora, Kalpit A.,

Guerra, Andrea,

Vargas, Sergio L.,

Lee, Andrew W.,

Zar, Heather J.,

Piedrahita, Jorge,

Sinha, Anushua,

Ishihara, Yasunori,

Ramilo, Octavio,

Zhang, Ying,

Madhi, Shabir A.,

Zang, Xiaowei

2025

Overview

Clesrovimab is a long-acting monoclonal antibody against respiratory syncytial virus fusion protein. In this phase 3, randomized trial involving 3614 healthy infants, clesrovimab reduced RSV disease and associated hospitalization.

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Publisher

Massachusetts Medical Society

Subject

Antibodies, Monoclonal, Humanized - administration & dosage

/ Antibodies, Monoclonal, Humanized - adverse effects

/ Antiviral Agents - administration & dosage

/ Antiviral Agents - adverse effects

/ Babies

/ Childhood Diseases

/ Confidence intervals