Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy Infants 3 to 5 Months of Age: A Randomized, Blinded, Single-center, Positive Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions.
研究概览
简要总结
Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American. In 1995, DTaP was successfully developed in China, and have been used in EPI at present. Because of effective immunity and little side reaction, DTaP has been widely recognized and accepted by the parents.
详细描述
Pertussis, diphtheria and tetanus are seriously infectious diseases for children. The world health organization (WHO) included the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP) into the expanded program on immunization (EPI), as a basic immunization. Since using the DTwP, it greatly reduced incidence of the three kinds of diseases. Thousands of children have been saved since its application. Although the DTwP was productively in against pertussis, diphtheria and tetanus, thallus of pertussis in the vaccine could cause more side reactions after vaccination. Many individuals did not want to be vaccinated. However, there was two large epidemics of pertussis during the period of 1977-1979 and 1981-1983. Since 2000, the basic immunization DTwP vaccine has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American. In 1995, DTaP was successful developed in the investigators' country, and is used in EPI at present. Because of effective immunity and causing little side reaction, DTaP has been widely recognized and accepted by the parents. This clinical trial is planning to evaluate the immunogenicity and safety of DTaP in 3-5 months infants .
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions.
时间窗: Day 7 post-each dose
Proportion of subjects reporting solicited injection-site reactions, solicited systemic reactions on day 7 post-each dose.
Immunogenicity after vaccination
时间窗: Day 28 post-dose 3
The seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody on day 28 post-dose 3. seroconversion is defined as post-third dose anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody concentrations ≥ protective antibody concentration, if pre-vaccination concentration is \< protective antibody concentration or ≥ 4 x protective antibody concentration if pre- vaccination concentrations ≥ protective antibody concentration.
次要结局
- Proportion of subjects reporting unsolicited injection-site and systemic reactions.(Day 28 post-each dose)
- The seropositivity rates of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.(Day 28 post-dose 3)
- Proportion of subjects with serious adverse events(SAE) occurring throughout the trial.(Day 0 up to 90 post-vaccination)
- Geometric mean concentration(GMC)of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.(Day 28 post-dose 3)
- Geometric mean fold increase（GMFI）of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibodies in serum on day 28 post-dose3.(Day 28 post-dose 3)