NCT04357522尚未招募3 期
A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,950
- 试验地点
- 3
- 主要终点
- Safety study endpoint
研究概览
简要总结
The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.
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 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
- •The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
- •The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
- •There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
- •Subaxillary body temperature <=37.0 C.
- •Determine health based on medical history, physical examination, and researcher's judgment.
排除标准
- •Have been vaccinated a listed or experimental pneumococcal vaccine.
- •History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
- •In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
- •History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
- •Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
- •History of pathological jaundice confirmed by diagnosis.
- •A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
- •Human serum gamma globulin injection after birth.
- •There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
- •Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
- •Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
- •Severe asthma.
- •Systemic rash, dermatophytes, skin pus or blister.
- •Participation in other drug clinical trials.
- •Anything that the researcher considers likely to affect the evaluation of the study.
结局指标
主要结局
Safety study endpoint
时间窗: 30 day after each vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Immunogenicity study endpoint
时间窗: 30 day after each vaccination
Percentage of participants with seroresponse to each vaccination
次要结局
未报告次要终点
研究者
研究点 (3)
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