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A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

NCT06083623 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2282

Last updated 2026-03-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

TNM001

single dose intramuscular injection

BIOLOGICAL

placebo

single dose intramuscular injection

Sponsors & Collaborators

  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hanmin Liu, MD · West China Second Hospital, Sichuan University

  • Enmei Liu, MD · Children's Hospital of Chongqing Medical University

  • Ying Wang · Zhuhai Trinomab Pharmaceutical Co., Ltd.

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
2023-09-11
Primary Completion
2025-06-16
Completion
2025-11-05
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06083623 on ClinicalTrials.gov