A Randomized,Blind, Positive-controlled Phase III Clinical Trial to 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
- 3 期
- 状态
- 已完成
- 入组人数
- 3,420
- 试验地点
- 1
- 主要终点
- Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
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
结局指标
主要结局
Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
时间窗: 30 days post vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Safety of PCV13i in preventing pneumococcal infections
时间窗: Within 30 days post each vaccination
Occurance of adverse reactions in all subjects
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
时间窗: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
时间窗: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
时间窗: 30 days post last dose of vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
次要结局
- Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)(30 days post last dose of vaccination)
- Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)(6 months post two doses)
- Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)(6 months post last dose of vaccination)
- Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)(30 days post three doses)
- Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)(6 months post one to three doses of vaccination)
- Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)(30 days post last dose of vaccination)
- Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)(30 days post three doses)
- Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)(30 days post two doses)
- Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)(30 days post two doses)