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 range0 Weeks – 12 Months
SexALL
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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
What they're measuring
1
Incidence of medically attended LRTI due to RT-PCR confirmed RSV