NCT06053853已完成4 期
Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
研究概览
简要总结
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
详细描述
To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.
To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
- •Subjects who received therapy with the intended DAT
排除标准
- •Receiving a different brand of Diphtheria Antitoxin (DAT)
结局指标
主要结局
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
时间窗: Within 10 days after injection
Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
次要结局
- The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)(Before injection of Diphtheria Antitoxin)
- The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)(Within 10 days after injection)
- The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)(Within 24 hours to 10 days after injection)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
TDAP Safety in Pregnant WomenPertussisNCT02209623Vanderbilt University375
已完成
4 期
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy InfantsRotavirusNCT02907216GlaxoSmithKline292
已完成
1 期
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in AdolescentsTetanusDiphtheriaPertussisNCT01689324Sanofi Pasteur, a Sanofi Company43
尚未招募
4 期
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children ( DTaP/DT )Vaccine ReactionNCT05870631Zhejiang Provincial Center for Disease Control and Prevention480
尚未招募
4 期
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old ChildrenVaccine ReactionNCT05870618Zhejiang Provincial Center for Disease Control and Prevention480