A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Launched by ZHUHAI TRINOMAB PHARMACEUTICAL CO., LTD. · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TNM001 to see how well it can prevent lower respiratory infections caused by the Respiratory Syncytial Virus (RSV) in infants. RSV is a common virus that can make babies very sick, especially during their first RSV season. The researchers want to find out if TNM001 is safe and effective for infants under one year old, including those who were born early or may have heart and lung issues.

To participate, infants must be less than one year old and either born prematurely (before 35 weeks) or full-term (35 weeks or more) and entering their first RSV season. However, babies with certain conditions, such as recent fevers, active RSV infections, or those receiving specific treatments, may not be eligible. If chosen for the trial, parents can expect to monitor their child's response to the treatment and any side effects, helping researchers learn more about how to protect infants from RSV infections in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Early and mid-term preterm infants (\<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.
• Exclusion Criteria:
• • 1. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization
• • 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
• • 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
• • 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. Prior history of a suspected or actual acute life-threatening event
• • 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
• • 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
• • 10.Receipt of RSV vaccine or mAb