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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

September 10, 2024

Study Completion Date

August 15, 2025

Conditions
Respiratory Syncytial Virus Infections
Interventions
DRUG

Nirsevimab

Participants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.

Trial Locations (9)

113-8519

Research Site, Bunkyō City

183-8561

Research Site, Fuchu-shi

813-0017

Research Site, Fukuoka

806-8501

Research Site, Kitakyusyu-shi

135-8577

Research Site, Kōtoku

830-0011

Research Site, Kurume-shi

852-8501

Research Site, Nagasaki

336-8522

Research Site, Saitama-shi

232 8555

Research Site, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

AstraZeneca

INDUSTRY

NCT06042049 - A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab | Biotech Hunter | Biotech Hunter