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

NCT06710925 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: TNM001-302
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

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

  150 days post dose

Study Arms (2)

TNM001

EXPERIMENTAL

Biological: TNM001

Placebo

PLACEBO COMPARATOR

Biological: placebo

Interventions

TNM001 BIOLOGICAL

single dose intramuscular injection

TNM001

placebo BIOLOGICAL

single dose intramuscular injection

Placebo

Eligibility Criteria

• Age: 0 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
• 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.
• Subject is available to complete the follow-up period.

You may not qualify if:

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

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (2)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, Sichuan, 404100, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Hanmin Liu

  West China Second Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

• Enmei Liu

  Children's Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: November 28, 2024
• Primary Completion: July 27, 2025
• Study Completion: December 14, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (2)