A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety of DTcP Vaccine in Healthy Children Aged Between 2 Months and 6 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Safety items of adverse reactions
研究概览
简要总结
Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.
详细描述
Study participants will receive a single booster dose of DTcP or a single booster dose of local DT in 4 to 6 years old ,a singel booster dose of DTcP or a single booster dose of DTaP in 18 to 24 months, three basic doses of DTcP or three doses of DTaP/ DTaP-IPV-Hib in 2 to 6 months.Safety profile will be assessed in all subjects up to Day 30 post 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 2months、3months、18-24months and 4-6 years old;
- •Willing to provide proof of identity;
- •Able to understand and sign the informed consent by guardians or trustees;
- •Able and willing comply with the requirements of the protocol by guardians or trustees;
- •Subjects of 2 months age have not been vaccinated with diphtheria, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
- •Subjects of 3 months have not been inoculated with vaccines containing diphtheria, Hib, 13-valent pneumococcal polysaccharide conjugate vaccine and Meningococcal Group AC Bivalent Meningococcal Conjugate Vaccine;volunteers of 3 months (C3 group) have not been inoculated with vaccines containing IPV;
- •Subjects aged 18-24 months who had completed the immunization program of 3 doses of DTaP and had without the fourth DTaP vaccine ;
- •Subjects aged 4-6 years who have completed the immunization program of 4 doses of DTaP or similar vaccines containing DTP component, but who have not received DT vaccine;
排除标准
- •Premature birth in infant under 1 year of age (delivery before the 37th week of pregnancy)or low birth weight (birth weight< 2300g for girls,<2500g for boys);
- •History of abnormal labor process or asphyxia rescue ;
- •Subjects who has a medical history of diphtheria, pertussis or tetanus;
- •In the past 30 days, individuals who have had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families;
- •Allergic person;
- •Any prior administration of blood products in last 3 month;
- •Any prior administration of other research medicines in last 1 month;
- •Plans to participate in or is participating in any other drug clinical study;
- •Any prior administration of attenuated live vaccine in last 14 days;
- •Any prior administration of subunit or inactivated vaccines in last 7 days;
- •Had fever before vaccination, Subjects with temperature >37.0°C on axillary setting;
- •According to the investigator's judgment, the subjects have any other factors that make them unfit to participate in the clinical trial
结局指标
主要结局
Safety items of adverse reactions
时间窗: within 30 days post-vaccination
Occurrence of adverse reactions
Safety items of SAE: Occurrence of SAE
时间窗: within 360 days post-vaccination
Occurrence of SAE
Safety itmes of laboratory measures: Occurrence of abnormal changes of laboratory measures
时间窗: the fourth day post-vaccination
Occurrence of abnormal changes of laboratory measures
次要结局
未报告次要终点