NCT05156528Unknown3 期
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 21,000
- 试验地点
- 9
- 主要终点
- Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
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 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants and children aged from 3 months to 5 years old;
- •The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
- •The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
- •Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
- •Axillary temperature ≤37.0℃;
- •According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition.
排除标准
- •Previous proven history of bacillary dysentery;
- •Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
- •Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
- •Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
- •With pathological jaundice confirmed by existing diagnosis;
- •History of thrombocytopenia or other coagulation disorders with definite diagnosis;
- •Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
- •Received immunoglobulin / blood products treatment within 3 months before vaccination;
- •Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
- •Subjects with the following diseases:
- •Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
- •Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
- •Severe asthma;
- •Systemic rash, dermatophyte, skin suppuration or blister;
- •History or family history of convulsion, epilepsy, encephalopathy, mental illness;
- •Planning to participate or currently participating in clinical trials of other vaccines or drugs;
- •Any situation that the investigator believed may affect the study evaluation.
结局指标
主要结局
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
时间窗: 30 day after each vaccination
Evaluate the protective rate for bacillary dysentery
次要结局
未报告次要终点
研究者
研究点 (9)
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