A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Safety items of Blood chemistry test
研究概览
简要总结
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.
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
- 6 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
- •Willing to provide proof of identity;
- •Without vaccination history of pneumococcal vaccine;
- •None-pregnancy or do not plan to pregnancy recently;;
- •Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
- •Volunteers of 8-17 years old and their guardians who willing sign informed consent;
- •Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
- •Able and willing comply with the requirements of the protocol ;
排除标准
- •Volunteers whose axillary body temperature was >37.0℃ before vaccination
- •Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
- •Volunteers who has a history of epilepsy, convulsions or psychosis;
- •-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, Volunteers with temperature >37.0°C on axillary setting;
- •According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
研究组 & 干预措施
vaccine 1A
Subjects received one dose of PCV13i at 18 to 49 years old
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 2A
Subjects received one dose of PCV13i at 50 years old and above
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 3A
Subjects received one dose of PCV13i at 6 to 17 years old
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 4A
Subjects received one dose of PCV13i at 2 to 5 years old
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 5A
Subjects received two doses of PCV13i at 7 months to 2 years old
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 6A
Subjects received three doses of PCV13i at 3,4,5 months of age
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 7A
Subjects received three doses of PCV13i at 2,4,6 months of age
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） (Biological)
vaccine 7B
Subjects received three doses of PCV13 at 2,4,6 months of age
干预措施: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Biological)
结局指标
主要结局
Safety items of Blood chemistry test
时间窗: day 4 post vaccination
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of heart rate
时间窗: day 4 post vaccination
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
Safety items of adverse reactions
时间窗: within 30 days post each vaccination
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Safety items of Urine test
时间窗: day 4 post vaccination
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of pressure value
时间窗: day 4 post vaccination
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
Safety items of Hematological examination
时间窗: day 4 post vaccination
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
Safety items of SAE
时间窗: within 6 months post last vaccination
Occurrence of SAE of each subject(Arm 1A-7B)
Safety items of adverse reactions
时间窗: within 7 days post each vaccination
Occurrence of adverse reactions of each subject(Arm 1A-7B)
次要结局
- immunogencity items of GMI by ELISA(day 30 post last vaccination)
- immunogencity items of GMT(day 30 post last vaccination)
- immunogencity items of seropositivity rates by ELISA(day 30 post last vaccination)
- immunogencity items of GMC by ELISA(day 30 post last vaccination)