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 Apr 2025 by AstraZeneca
AstraZeneca
IQVIA RDS Inc.
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
This is a Phase 3 randomized, double-blind, placebo-controlled, single-dose study to determine if nirsevimab will prevent medically attended RSV-confirmed LRTI in healthy preterm and term infants entering their first RSV season. The population to be enrolled is healthy preterm and term infants > 29 weeks 0 days GA entering their first RSV season, who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local or national guidelines. Approximately 800 subjects will be randomized 2:1 to receive a single IM dose of nirsevimab 50 mg (if weight < 5 kg) or 100 mg (if weight ≥ 5 kg) (N = 530) or placebo (N = 270). Randomization will be stratified by subject age at the time of randomization (≤ 3 months, > 3 to ≤ 6 months, > 6 months), and by GA (< 35 weeks GA, ≥ 35 weeks GA). Enrollment of infants > 6 months of age will be limited to approximately 100. All subjects will be followed through 1 year after dose administration. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. Around 40 investigational study centres participate in the study.
Location
Location
Chengdu, China, 610041
Location
Guangzhou, China, 510120
Location
Shenzhen, China, 518106
Location
Zhongshan, China, 528400
Location
Kunming, China, 650101
Location
Guangzhou, China, 510280
Location
Suzhou, China, 215002
Location
changsha, China, 410005
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) |
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