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

Trinomab

Status and phase

Not yet enrolling

Phase 3

Conditions

Respiratory Syncytial Virus Infections

Treatments

Biological: placebo

Biological: TNM001

Study type

Interventional

Funder types

Industry

Identifiers

NCT06710925

TNM001-302

Details and patient eligibility

About

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.

Enrollment

201 estimated patients

Sex

All

Ages

Under 12 months old

Volunteers

Accepts Healthy Volunteers

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
1. History of RSV infection
1. Being hospitalized at the time of randomization
1. Currently receiving or expected to receive immunosuppressive therapy during the study period.
1. Renal impairment or hepatic dysfunction
1. Nervous system disease or neuromuscular disease
1. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
1. 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