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

NCT05110261 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China

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)

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2025-11-24
Completion
2025-11-24

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110261 on ClinicalTrials.gov