A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tra… (NCT06083623) | Clinical Trial Compass
CompletedPhase 2/3
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
China2,282 participantsStarted 2023-09-11
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.
Who can participate
Age range0 Years – 1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of medically attended LRTI due to RT-PCR confirmed RSV