A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants (NCT06710925) | Clinical Trial Compass
CompletedPhase 3
A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants
China315 participantsStarted 2024-11-28
Plain-language 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.
Who can participate
Age range
0 Weeks – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial for RSV in high-risk infants — since it's already completed, would my child potentially benefit from the results, and is TNM001 available or moving toward approval based on what was found?
2The trial measured whether infants had fewer doctor or hospital visits for lower respiratory tract infections confirmed by RSV testing — does my child's current situation put them at the kind of high risk that was being studied here, and how does that affect our options?
3Since this study is completed but the results may not yet be publicly available, can you look into whether the findings showed any safety concerns for high-risk infants that we should factor into our decision-making?
4Are there already approved RSV preventions, like nirsevimab, that might be a better-understood option for my child right now compared to waiting to see if TNM001 becomes available?
5Given that my infant is considered high-risk for RSV, what is the standard of care you'd recommend today, and how might the results from this completed trial change that recommendation once they're published?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of medically attended LRTI due to RT-PCR confirmed RSV