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Completed

NCT Number: NCT06710925

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

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.

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

0 week–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNM001

Biological

single dose intramuscular injection

Placebo

Biological

single dose intramuscular injection

Primary outcomes

  1. Incidence of medically attended LRTI due to RT-PCR confirmed RSV

    Time frame: 150 days post dose

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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