Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,760
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.
详细描述
This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.
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
- Double (Participant, Investigator)
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
- •Healthy volunteer ≥ 2 years old;
- •Proven legal identity;
- •Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old;
- •Complying with the requirement of the study protocol;
排除标准
- •Prior vaccination with pneumococcal vaccine;
- •History of bacterial pneumonia within 3 years prior to this study;
- •Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;
- •History of allergy to any vaccine or vaccine ingredient;
- •Receipt of any of the following products:
- •Blood product within 3 months prior to study entry;
- •Any live attenuated vaccine within 28 days prior to study entry;
- •Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
- •Any immunosuppressant within 6 month prior to study entry;
- •Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
- •History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Axillaty temperature > 37.0 °C;
- •Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;
- •Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):
- •Receipt of any other investigational or unregistered product (drug or vaccine);
- •Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days, except for inhalant or locally administrated corticosteroid;
- •Receipt of immunoglobulin and/or blood product;
- •Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
结局指标
主要结局
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
时间窗: 28 days
For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
次要结局
- The incidences of adverse events (AEs)(28 days)
- The increases of relative antibody concentration against each of the 23 pneumococcal serotypes(28 days)