Study identifier:D5290C00006
ClinicalTrials.gov identifier:NCT05110261
EudraCT identifier:2021-005075-38
CTIS identifier:N/A
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in China
lower respiratory tract infection
Phase 3
Yes
Nirsevimab, Placebo
All
800
Interventional
0 Years - 1 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
IQVIA RDS Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Nirsevimab Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. | Drug: Nirsevimab Drug: injection, 100 mg/mL, a single fixed IM dose of 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg)on day 1 only. Other Name: MEDI8897 |
Placebo Comparator: Placebo Subjects will be randomized 2:1 to receive a single IM dose of nirsevimab or placebo. | Drug: Placebo Commercially available 0.9% (w/v) saline (sterile for human use) fixed IM dose of 0.5 mL (if weight <5 kg) or 1.0 mL (if weight >=5 kg) |