8 completed, 8 recruiting, 4 not yet recruiting, 2 active not recruiting. 5 Phase 3, 4 Phase 4, 2 Phase 1, 2 Phase 2, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis Prior exposure to prophylactic treatment with Abrysvo or nirsevimab/clesrovimab, Non-exposure to prior prophylactic treatment - Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 300 | 2026-11-15 | 2026-10-26 | |
| THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness Nirsevimab (RSV-specific monoclonal antibody) - Respiratory Syncytial Virus (RSV), Respiratory Infection Virus | Phase 4 | Recruiting | Menzies School of Health Research | 1000 | 2026-06-17 | 2026-10-07 |
| Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination Nirsevimab, Abrysvo - RSV Immunization | Phase 3 | Recruiting | Centre Hospitalier Annecy Genevois | 1000 | 2026-05-06 | 2026-05-27 |
| Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution - Respiratory Syncytial Virus (RSV) | Phase 1 / Phase 2 | Not yet recruiting | Shanghai Institute Of Biological Products | 36 | 2026-01-15 | 2026-01-23 |
| The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database. Effectiveness of passive immunization with nirsevimab - Infant Wheeze, Preschool Age Children | Not yet recruiting | Hospices Civils de Lyon | 218000 | 2026-01-01 | 2026-01-08 | |
| Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed - Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection | Active not recruiting | Bogotá District Health Secretariat | 1097 | 2026-01-01 | 2026-08-06 | |
| Safety of RSV Preventive Monoclonal Antibody Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody - Fever, Adverse Event Following Immunisation | Phase 4 | Recruiting | Duke University | 524 | 2025-10-02 | 2026-03-16 |
| A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea Nirsevimab - Respiratory Syncytial Virus | Recruiting | Sanofi | 3000 | 2025-10-02 | 2025-12-03 | |
| 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. Abrysvo, Nirsevimab - RSV Immunization | Phase 3 | Not yet recruiting | PENTA Foundation | 1500 | 2025-09-01 | 2025-06-27 |
| A Clinical Trial of SIBP-A16 Injection in Healthy Adults SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution - Respiratory Syncytial Virus (RSV) | Early Phase 1 | Recruiting | Shanghai Institute Of Biological Products | 140 | 2025-08-17 | 2025-11-25 |
| Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants Nirsevimab - RSV Infections, Lower Respiratory Tract Infections | Completed | Han Tongyan | 816 | 2025-08-01 | 2026-02-03 | |
| Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India Nirsevimab - RSV Immunization | Phase 4 | Active not recruiting | Sanofi | 110 | 2025-07-31 | 2026-03-23 |
| Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age. Nirsevimab - Respiratory Synctial Virus Infections | Recruiting | Meyer Children's Hospital IRCCS | 138 | 2024-12-04 | 2025-03-10 | |
| Real-World Effectiveness of Perinatal RSV Immunoprophylaxis Nirsevimab - RSV Infection | Recruiting | Yale University | 3750 | 2024-10-28 | 2026-10-23 | |
| The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products Abrysvo, Beyfortus - Respiratory Syncytial Virus Infection | Phase 4 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 181 | 2024-09-19 | 2026-05-11 |
| Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL) Nirsevimab - RSV | Unknown | Instituto Sistemas Complejos de Ingeniería | 160000 | 2024-04-01 | 2024-07-22 | |
| BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study) Nirsevimab - Respiratory Syncytial Virus | Completed | Sanofi Pasteur, a Sanofi Company | 49680 | 2024-04-01 | 2025-11-05 | |
| Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization Nirsevimab - RSV Infection | Recruiting | Federico Martinón Torres | 42000 | 2023-09-25 | 2023-12-26 | |
| A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab Nirsevimab - Respiratory Syncytial Virus Infections | Phase 3 | Completed | AstraZeneca | 33 | 2023-07-27 | 2026-04-16 |
| 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 Nirsevimab - RSV Immunization, Healthy Volunteer | Phase 3 | Completed | Sanofi Pasteur, a Sanofi Company | 8057 | 2022-08-08 | 2025-10-09 |
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Respiratory Syncytial Virus Infections (8) · Bronchiolitis, Viral (1) · Fever (1) · Premature Birth (1) · Respiratory Tract Infections (1)
AstraZeneca (4) · Sanofi (2) · Sanofi Pasteur, a Sanofi Company (2) · Shanghai Institute Of Biological Products (2) · Assistance Publique - Hôpitaux de Paris (1) · Bogotá District Health Secretariat (1) · Centre Hospitalier Annecy Genevois (1) · Duke University (1) · Federico Martinón Torres (1) · Han Tongyan (1) · Hospices Civils de Lyon (1) · Instituto Sistemas Complejos de Ingeniería (1) · Menzies School of Health Research (1) · Meyer Children's Hospital IRCCS (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1)
China (5) · United States (5) · France (4) · Japan (2) · Spain (2) · United Kingdom (2) · Australia (1) · Belgium (1) · Chile (1) · Colombia (1) · Germany (1) · India (1) · Italy (1) · Poland (1) · South Africa (1)
Carlos R Oliveira, MD (1) · Hanwen Liu (1) · Michael J Smith, MD (1) · Pierre Frange (1)
PMID 38157500, PMID 38701823, PMID 38738683, PMID 40314706, PMID 40379431, PMID 40513593, PMID 41539320, PMID 41856594
2025 (3), 5UM1AI148684-04 (1), R01AI179874 (1)