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

CanSino Biologics Inc.1 个研究点分布在 1 个国家目标入组 3,420 人开始时间: 2021年4月13日最近更新: 2024年4月2日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: CanSino Biologics Inc.
入组人数: 3,420
试验地点: 1
主要终点: Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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