Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2022-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants

NCT06939777

Tetanus

NOT_YET_RECRUITING PHASE1/PHASE2

A Study to Evaluate the Safety and Immunogenicity of a Single Dose of Adsorbed Tetanus Vaccine in a Population Aged 18 Years and Over

NCT06123663

Tetanus

COMPLETED PHASE1

To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

NCT02361866

Bacterial Infections

COMPLETED PHASE3

A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children

NCT02991872

Virus Diseases

COMPLETED PHASE4

Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

NCT02526745

Herpes Zoster

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tetanus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TNM002 low dose

Participants receive a single intramuscular injection of TNM002 with low dose on Day 1

Group Type EXPERIMENTAL

TNM002 (low dose)

Intervention Type BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

TNM002 medium dose

Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1

Group Type EXPERIMENTAL

TNM002 (medium dose)

Intervention Type BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

TNM002 high dose

Participants receive a single intramuscular injection of TNM002 with high dose on Day 1

Group Type EXPERIMENTAL

TNM002 (high dose)

Intervention Type BIOLOGICAL

Single dose of TNM002 administered by intramuscular injection

Human Tetanus Immunoglobulin (HTIG)

Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1

Group Type ACTIVE_COMPARATOR

HTIG

Intervention Type BIOLOGICAL

Single dose of HTIG administered by intramuscular injection

Placebo

Participants receive a single intramuscular injection of placebo on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Single dose of placebo administered by intramuscular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TNM002 (low dose)

Single dose of TNM002 administered by intramuscular injection

Intervention Type BIOLOGICAL

TNM002 (medium dose)

Single dose of TNM002 administered by intramuscular injection

Intervention Type BIOLOGICAL

TNM002 (high dose)

Single dose of TNM002 administered by intramuscular injection

Intervention Type BIOLOGICAL

HTIG

Single dose of HTIG administered by intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Single dose of placebo administered by intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Chinese male or female adults aged ≥ 18 years;
2. Healthy volunteers or volunteers with stable chronic diseases;
3. Volunteers who provide signed written informed consent form.

Exclusion Criteria

1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
3. History of alcohol or other substance abuse.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes