Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

November 24, 2021

Primary Completion Date

November 24, 2025

Study Completion Date

November 24, 2025

Conditions
Lower Respiratory Tract Infection
Interventions
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.

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)

Trial Locations (33)

41081

Research Site, Linfen

63003

Research Site, Tangshan

100191

Research Site, Beijing

134000

Research Site, Tonghua

210009

Research Site, Nanjing

214023

Research Site, Wuxi

215002

Research Site, Suzhou

300074

Research Site, Tianjin

300201

Research Site, Tianjin

310006

Research Site, Hangzhou

310013

Research Site, Hangzhou

311800

Research Site, Shaoxing

314000

Research Site, Jiaxing

315012

Research Site, Ningbo

325027

Research Site, Wenzhou

410005

Research Site, Changsha

410008

Research Site, Changsha

415003

Research Site, Changde

450018

Research Site, Zhengzhou

453000

Research Site, Xinxiang

472000

Research Site, Sanmenxia

510120

Research Site, Guangzhou

510150

Research Site, Guangzhou

510280

Research Site, Guangzhou

515041

Research Site, Shantou

518106

Research Site, Shenzhen

528400

Research Site, Zhongshan

572000

Research Site, Sanya

610000

Research Site, Chengdu

610041

Research Site, Chengdu

650101

Research Site, Kunming

Unknown

Research Site, Langfang

041099

Research Site, Linfen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

IQVIA RDS Inc.

INDUSTRY

lead

AstraZeneca

INDUSTRY