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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 55
- 主要终点
- Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TNM002
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
干预措施: TNM002 (Drug)
Human tetanus immunoglobulin (HTIG)
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
干预措施: Human tetanus immunoglobulin (HTIG) (Drug)
结局指标
主要结局
Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.
时间窗: Baseline up to 12 hours after receipt of study drug
Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose
时间窗: Baseline up to 12 hours after receipt of study drug
The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL.
次要结局
- Tetanus protection rate (1 - tetanus incidence)(Up to 28 days after receipt of study drug)
- Tetanus Protection Rate on Day 28 Post-dose(Up to 28 days after receipt of study drug)