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

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.

Timeline

Start

2024-11-28

Primary completion

2025-07-27

Completion

2025-12-14

Drugs

Indications