nirsevimab: Clinical Trials

3 completed, 1 not yet recruiting, 1 recruiting. 5 Phase 3.

By phase and status

Phase	Trials	Status
Phase 3	5	Completed 3, Not yet recruiting 1, Recruiting 1

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Trials (filtered) newest first · largest first

All 5 trials

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
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
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 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
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China Nirsevimab, Placebo - Lower Respiratory Tract Infection	Phase 3	Completed	AstraZeneca	800	2021-11-24	2026-10-15

Conditions studied

Respiratory Syncytial Virus Infections (1)  ·  Respiratory Tract Infections (1)

Sponsors

AstraZeneca (2)  ·  Centre Hospitalier Annecy Genevois (1)  ·  PENTA Foundation (1)  ·  Sanofi Pasteur, a Sanofi Company (1)

Countries

France (2)  ·  China (1)  ·  Germany (1)  ·  Japan (1)  ·  United Kingdom (1)

Top investigators

Pierre Frange (1)

Results publications

PMID 38157500, PMID 40379431

NIH funding

2025 (3)