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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06710925

Enrollment

315

Registered

2024-11-29

Start date

2024-11-28

Completion date

2025-12-14

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Brief 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.

Interventions

BIOLOGICALTNM001

single dose intramuscular injection

BIOLOGICALplacebo

single dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

0 Weeks to 12 Months

Healthy volunteers

Yes

Inclusion criteria

* 1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening. * 2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection. * 3.Subject is available to complete the follow-up period.

Exclusion criteria

* 1\. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization * 2\. History of RSV infection * 3\. Being hospitalized at the time of randomization * 4\. Currently receiving or expected to receive immunosuppressive therapy during the study period. * 5\. Renal impairment or hepatic dysfunction * 6\. Nervous system disease or neuromuscular disease * 7\. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded. * 8\. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period. * 9.Receipt of RSV vaccine or mAb * 10.Receiving blood products before randomization

Design outcomes

Primary

Measure	Time frame
Incidence of medically attended LRTI due to RT-PCR confirmed RSV	150 days post dose

Countries

China

Contacts

PRINCIPAL_INVESTIGATORHanmin Liu

West China Second Hospital, Sichuan University

PRINCIPAL_INVESTIGATOREnmei Liu

Children's Hospital of Chongqing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026