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A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants

NCT06710925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-03-05

No results posted yet for this study

Summary

This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 sites in China.

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 · West China Second Hospital, Sichuan University

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2025-07-27
Completion
2025-12-14
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 NCT06710925 on ClinicalTrials.gov