Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Study Overview
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Brief Summary
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TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Conditions
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Tetanus

Intervention / Treatment
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* Drug: TNM002
* Drug: Human tetanus immunoglobulin (HTIG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese male or female adults aged ≥ 18 years; Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus; Participants who provide signed written informed consent form. Exclusion Criteria: Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins; Suspect or diagnosed as tetanus; Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; Current alcohol abuse, drug abuse or drug addiction Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM002<br>If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002 | Drug: TNM002<br>* Dosage Form: Injection, solution Route of administration: IM gluteal injection<br>|
| Active Comparator: Human tetanus immunoglobulin (HTIG)<br>If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG | Drug: Human tetanus immunoglobulin (HTIG)<br>* Dosage Form: Injection, solution Route of administration: IM gluteal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. |  | Baseline up to 12 hours after receipt of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tetanus protection rate (1 - tetanus incidence) |  | Up to 28 days after receipt of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetanus, Prophylaxis