Nirsevimab

BIOLOGICAL17 trials

Conditions

Evaluate PK ProfileHealthy VolunteerLower Respiratory Tract InfectionLower Respiratory Tract InfectionsRSVRSV ImmunizationRSV InfectionRSV Infections

Early Phase 1

A Clinical Trial of SIBP-A16 Injection in Healthy Adults

RecruitingNCT07106918

Shanghai Institute Of Biological ProductsRespiratory Syncytial Virus (RSV)

Start: 2025-08-17End: 2027-04-30Target: 140Updated: 2025-11-25

Phase 1

Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults

CompletedNCT04840849

AstraZenecaEvaluate PK Profile

Start: 2021-06-22End: 2021-11-18Updated: 2023-11-02

Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants

Not yet recruitingNCT07363837

Shanghai Institute Of Biological ProductsRespiratory Syncytial Virus (RSV)

Start: 2026-01-15End: 2027-03-31Target: 36Updated: 2026-01-23

Phase 2

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

CompletedNCT04484935

AstraZenecaRSV Infection

Start: 2020-08-19End: 2023-02-17Updated: 2023-11-15

Phase 3

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

CompletedNCT05110261

AstraZenecaLower Respiratory Tract Infection

Start: 2021-11-24End: 2025-11-24Updated: 2026-03-30

Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life

CompletedNCT05437510

Sanofi Pasteur, a Sanofi CompanyHealthy Volunteer, RSV Immunization

Start: 2022-08-08End: 2025-04-09Updated: 2025-10-09

A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

CompletedNCT06042049

AstraZenecaRespiratory Syncytial Virus Infections

Start: 2023-07-27End: 2025-07-24Updated: 2026-04-16

Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.

Not yet recruitingNCT07041190

PENTA FoundationRSV Immunization

Start: 2025-09-30End: 2028-12-31Target: 1500Updated: 2025-06-27

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

RecruitingNCT07232706

Centre Hospitalier Annecy GenevoisRSV Immunization

Start: 2026-05-06End: 2029-05-05Target: 1000Updated: 2026-05-27

Phase 4

Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

Active, not recruitingNCT07109297

SanofiRSV Immunization

Start: 2025-07-31End: 2026-06-30Updated: 2026-03-23

Unknown Phase

Real-World Effectiveness of Perinatal RSV Immunoprophylaxis

RecruitingNCT06172660

Yale UniversityRSV Infection

Start: 2024-10-28End: 2028-12-30Target: 3750Updated: 2025-08-14

Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization

RecruitingNCT06180993

Federico Martinón TorresRSV Infection

Start: 2023-09-25End: 2026-10-31Target: 42000Updated: 2023-12-26

BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)

CompletedNCT06325332

Sanofi Pasteur, a Sanofi CompanyRespiratory Syncytial Virus

Start: 2024-04-01End: 2025-06-30Updated: 2025-11-05

Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)

RecruitingNCT06511687

Instituto Sistemas Complejos de IngenieríaRSV

Start: 2024-04-01End: 2024-10-01Target: 160000Updated: 2024-07-22

Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.

RecruitingNCT06856967

Meyer Children's Hospital IRCCSRespiratory Synctial Virus Infections

Start: 2024-12-04End: 2025-04-30Target: 138Updated: 2025-03-10

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

RecruitingNCT07200206

SanofiRespiratory Syncytial Virus

Start: 2025-10-02End: 2029-09-26Target: 3000Updated: 2025-12-03

Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants

CompletedNCT07382219

Han TongyanLower Respiratory Tract Infections, RSV Infections

Start: 2025-08-01End: 2025-10-31Updated: 2026-02-03

2026-03-19

Impact of universal nirsevimab prophylaxis in infants on hospital and primary care outcomes across two respiratory syncytial virus seasons in Galicia, Spain (NIRSE-GAL): a population-based prospective observational study.

2026-01-12

564. Nirsevimab effectiveness in infants against respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) and related healthcare utilization

Open Forum Infectious Diseases2026-01-01

Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): a retrospective observational study.

2025-06-1012 citations

180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial.

2025-06-0120 citations

Respiratory syncytial virus-related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study.

2025-05-021 citations

169. Universal Immunization Strategy Against Respiratory Syncytial Virus (RSV) Prevention in Chile with Nirsevimab during the 2024 Winter Season: First Southern Hemisphere Nationwide Effectiveness Data

Open Forum Infectious Diseases2025-01-292 citations

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

Pathogens2024-06-1323 citations

Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol

Human Vaccines & Immunotherapeutics2024-05-1314 citations

Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study.

2024-04-30166 citations

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

New England Journal of Medicine2023-12-27295 citations

Safety, Tolerability, and Pharmacokinetics of Nirsevimab for the Prevention of RSV Disease in Immunocompromised Children Aged ≤24 Months: Music, an Open Label, Phase 2 Trial

Blood2023-11-023 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