NCT04278248已完成3 期
A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,940
- 试验地点
- 1
- 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 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 years old and above healthy people.
- •Subject or legal representative who consent and has signed written informed consent.
- •Subject or legal representative who is able to comply with all study procedures.
- •Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- •Allergic history after vaccination.
- •Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
- •Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
- •Known immunological impairment or dysfunction.
- •Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
- •Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
- •Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
- •In pregnancy or lactation or pregnant women.
- •Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
- •Any contraindications that investigators consider related to vaccination.
研究组 & 干预措施
Positive control group
Active Comparator
Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose
干预措施: 23-Valent Pneumococcal Polysaccharide Vaccine (Biological)
experimental group
Experimental
Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose
干预措施: 23-Valent Pneumococcal Polysaccharide Vaccine (Biological)
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 (1)
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