A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants
NCT ID: NCT06710925
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
201 participants
INTERVENTIONAL
2024-11-30
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TNM001
TNM001
single dose intramuscular injection
Placebo
placebo
single dose intramuscular injection
Interventions
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TNM001
single dose intramuscular injection
placebo
single dose intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Weeks
12 Months
ALL
Yes
Sponsors
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Zhuhai Trinomab Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmin Liu
Role: PRINCIPAL_INVESTIGATOR
West China Second Hospital, Sichuan University
Enmei Liu
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Chongqing Medical University
Locations
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West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Children's Hospital of Chongqing Medical University
Chongqing, Sichuan, China
Countries
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Central Contacts
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Other Identifiers
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TNM001-302
Identifier Type: -
Identifier Source: org_study_id