Trials / Completed
CompletedNCT06710925
A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Monoclonal Antibody TNM001 Injection Against Respiratory Syncytial Virus in High-risk Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 315 (actual)
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 0 Weeks – 12 Months
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TNM001 | single dose intramuscular injection |
| BIOLOGICAL | placebo | single dose intramuscular injection |
Timeline
- Start date
- 2024-11-28
- Primary completion
- 2025-07-27
- Completion
- 2025-12-14
- First posted
- 2024-11-29
- Last updated
- 2026-03-05
Locations
2 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06710925. Inclusion in this directory is not an endorsement.