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

Trinomab

Status and phase: Completed; Phase 3

Conditions: Tetanus

Treatments: Drug: TNM002; Drug: Human tetanus immunoglobulin (HTIG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05664750

TNM002-301

Details and patient eligibility

About

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.

Enrollment: 675 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese male or female adults aged ≥ 18 years;
2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
3. Participants who provide signed written informed consent form.

Exclusion criteria

1. 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;
2. Suspect or diagnosed as tetanus;
3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
5. Current alcohol abuse, drug abuse or drug addiction

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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675 participants in 2 patient groups

TNM002

Experimental group

Description:

If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002

Treatment:

Drug: TNM002

Human tetanus immunoglobulin (HTIG)

Active Comparator group

Description:

If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG

Treatment:

Drug: Human tetanus immunoglobulin (HTIG)