MEDI8897

DRUG3 trials

Sponsors

MedImmune LLC, AstraZeneca

Conditions

Respiratory Syncytial Virus Infections

Phase 2

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

CompletedNCT02878330

MedImmune LLCRespiratory Syncytial Virus Infections

Start: 2016-11-03End: 2018-12-06Updated: 2019-10-14

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

CompletedNCT03959488

AstraZenecaRespiratory Syncytial Virus Infections

Start: 2019-07-30End: 2023-01-20Updated: 2023-09-21

Phase 3

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

CompletedNCT03979313

AstraZenecaRespiratory Syncytial Virus Infections

Start: 2019-07-23End: 2023-03-21Updated: 2024-02-28

Related Papers

P-1521. Prophylactic Immunization with Nirsevimab Does Not Impair the Development of Natural Antibody Responses to the Pre-fusion Conformation of the Respiratory Syncytial Virus Fusion Protein

Open Forum Infectious Diseases2026-01-01

Lower Respiratory Tract Infections Following Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab Immunization Versus Placebo: Analysis From a Phase 3 Randomized Clinical Trial (MELODY).

2025-10-016 citations

Comprehensive Summary of Safety Data on Nirsevimab in Infants and Children from All Pivotal Randomized Clinical Trials

Pathogens2024-06-1323 citations

Infants Receiving a Single Dose of Nirsevimab to Prevent RSV Do Not Have Evidence of Enhanced Disease in Their Second RSV Season

Journal of the Pediatric Infectious Diseases Society2024-01-1440 citations

1934. Nirsevimab is Associated with Higher and More Sustained RSV Neutralizing Antibody Responses Compared with Standard of Care Palivizumab: Observations from a 2:1 Randomized, Phase 2/3 Trial in Medically Vulnerable Children (MEDLEY)

Open Forum Infectious Diseases2023-11-272 citations

Fc-mediated functions of nirsevimab complement direct respiratory syncytial virus neutralization but are not required for optimal prophylactic protection

Frontiers in Immunology2023-10-1128 citations

Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials.

2023-07-1953 citations

Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

New England Journal of Medicine2022-03-02881 citations

LB13. The Efficacy and Impact in Heathy Infants of Nirsevimab on Medically Attended RSV Lower Respiratory Tract Infection

Open Forum Infectious Diseases2021-11-012 citations

Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.

2020-07-01538 citations

Antibodies to watch in 2020.

2020-01-01328 citations