Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children：a Randomized, Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Seropositive rates after the vaccination
研究概览
简要总结
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
详细描述
A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Wuhan Biological Products Co., LTD. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 72 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥ 6 on the day of enrollment;
- •Informed consent should be signed and dated by the participants;
- •The participant's legal guardian is able to attend all planned follow-up visits and comply with all study procedures;
- •The participants have received 4 doses of acellular TDap vaccine and have not received any immunization agents related to diphtheria, tetanus, and pertussis in the past 3 years;
- •The participant has no diease history of pertussis, diphtheria or tetanus;
- •≥ 14 days interval between the last vaccination;
- •Body temperature was ≤37.3℃.
排除标准
- •Being allergic to any component of vaccines ；
- •A history of severe allergic reactions to any vaccine (for example acute allergic reaction, angioneurotic edema, dyspnea, etc）；
- •Having a history or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy and other progressive neurological diseases;
- •Participants are suffering from immunodeficiency, receiving immunosuppressant therapy (oral steroid hormones) during treatment for malignancy, or having low immunity due to HIV, or having congenital immune disorders in close family members;
- •Injection of non-specific immunoglobulin within 1 month before enrollment;
- •Participants are suffering from acute febrile diseases and infectious diseases;
- •A history of clearly diagnosed thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection;
- •Participants with severe chronic diseases or acute episodes of chronic diseases;
- •Participants with infectious, suppurative and allergic skin diseases;
- •Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
结局指标
主要结局
Seropositive rates after the vaccination
时间窗: 28-42 days after the dose of DTaP or DT
The percentage of participants with positive antibody against pertussis，diphtheria and tetanus
Seroconversion rates of the vaccination
时间窗: 28-42 days after the dose of DTaP or DT
Defined as any positive antibody response against pertussis，diphtheria，tetanus in children who were seronegative prior to the vaccination, or at least a fourfold increase in antibody levels against pertussis for children who had pre-existing positive antibodies
次要结局
- Geometric mean antibody concentrations before the vaccination(before the dose of DTaP or DT)
- Geometric mean antibody concentrations after the vaccination(28-42 days after the dose of DTaP or DT)
- Safety of the DTaP or DT vaccine immunization(28 days after the vaccination)