NCT04700618已完成4 期
A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Antibody doubling rate
研究概览
简要总结
Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.
详细描述
- Antibody double growth rate in 28-40 days after immunization;
- Antibody GMC level in 28-40days after immunization;
- Incidence of adverse reactions in 0-30days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age was 60-70 years old on the day of enrollment;
- •The subjects have signed the informed consent and signed the date;
- •The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
- •The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
- •The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
排除标准
- •With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- •Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
- •4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
研究组 & 干预措施
Control group
Placebo Comparator
The control group had never been vaccinated with any pneumococcal vaccine.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
Study group
Experimental
The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years.
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
结局指标
主要结局
Antibody doubling rate
时间窗: The blood collection time was 28-40 days after vaccination.
The difference of serum antibody double growth level between the two groups was compared.
次要结局
- Antibody GMC level(The blood collection time was 28-40 days after vaccination.)
- Incidence of adverse reactions(Within 30 days after vaccination.)
研究者
研究点 (1)
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