NCT02736240已完成3 期
Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Developed Cooperatively by YunNan Walvax Biotechnology Co., Lt and Yuxi Walvax Biotechnology Co., Lt Among 2-71 Months (the Youngest Could be 6 Weeks) Healthy Infants and Toddlers by Randomized Blind Method With Similar Control in Multi-centers.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,760
- 主要终点
- positive rate after booster dose
研究概览
简要总结
The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator;
- •The statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form;
- •The subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol;
- •Never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days);
- •The auxillary temperature ≤37℃.
排除标准
- •Has already been immunized with pneumococcus vaccine no matter it is experimental or marketed;
- •With the history of invasive disease caused by streptococcus pneumonia by culture;
- •With the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product;
- •Infant that the birth weight is lighter than 2.5 kg;
- •With the history or the family history of seizure, epilepsy, cerebropathy and psychosis ;
- •Infant with the abnormal labor (difficult labor, deliver with apparatus) or with the history of asphyxia or nervous damage;
- •With the history of thrombocytopenia or other coagulation disorders by definite diagnosis;
- •Infant or toddler with pathological jaundice by diagnosis;
- •Be known with or suspected with immunological dysfunction, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), HIV infection etc. ;
- •Be known with serious congenital malformation or serious chronic disease; suffer from congenital malformation or be diagnosed with serious chronic disease (eg. Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome);
- •Be known with or suspected with diseases including: disease of respiratory system, acute infection or the active period of chronic disease, serious cardiovascular disease, hepatic-nephrotic disease, malignant tumor, skin disease;
- •Has taken blood product or globulin (the hepatitis B immune globulin is allowed);
- •Be participating in other clinical trials;
- •Any other situation which is considered to influence the evaluation of the study by investigators .
结局指标
主要结局
positive rate after booster dose
时间窗: 30 days after booster dose
the rate of the immunoglobulin G ≥0.35μg/ml after booster dose
GMC after booster dose
时间窗: 30 days after booster dose
geometrical mean concentration of immunoglobulin G after booster dose
positive rate after infant doses
时间窗: 30 days after infant doses
the rate of the immunoglobulin G ≥0.35μg/ml after infant doses
GMC after infant doses
时间窗: 30 days after infant doses
geometrical mean concentration of immunoglobulin G after infant doses
次要结局
未报告次要终点
研究者
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