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

Study identifier:D5290C00006

ClinicalTrials.gov identifier:NCT05110261

EudraCT identifier:2021-005075-38

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

lower respiratory tract infection

Phase

Phase 3

Healthy volunteers

Yes

Study drug

Nirsevimab, Placebo

Sex

All

Estimated Enrollment

800

Study type

Interventional

Age

0 Years - 1 Years

Date

Study Start Date: 24 Nov 2021
Estimated Primary Completion Date: 02 May 2025
Estimated Study Completion Date: 28 Nov 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA RDS Inc.

Inclusion and exclusion criteria