A Multi-centered, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Combined Immunization of 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) and Quadrivalent Inactivated Influenza Vaccine (IIV4)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,224
- 试验地点
- 4
- 主要终点
- Seroconversion rate (IIV4)
研究概览
简要总结
Subjects will be recruited and divided into 3 groups:
- Experimental Group (408 subjects): combined immunization of PPV23 and IIV4;
- Control Group A (408 subjects): IIV4 only;
- Control Group B (408 subjects): PPV23 only;
All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.
详细描述
To evaluate the safety and immunogenicity of simultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4) , we design this randomized, parallel controlled study . 1224 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B), each group includes 408 subjects respectively.
Each 408-subject group is divided again into 4 age-based subgroups: ① 3-8 years old; ② 9-18 years old; ③ 19-49 years old ; ④ over 50 years old; each subgroup includes 102 subjects respectively.
408 subjects from experimental group will be simultaneously administrated with one dose of IIV (0.5 ml) and one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
408 subjects from control group A will be only administrated with one dose of IIV (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
408 subjects from control group B will be only administrated with one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects aged no younger than 3 years old on the day of recruitment;
- •with valid informed consent signed by parent(s) or guardian(s);
- •parent(s) or guardian(s) are able to attend all scheduled appointments and comply with all study instructions;
- •subjects have not received any seasonal influenza vaccine or pneumonia vaccine before;
- •axillary temperature ≤37.0℃
排除标准
- •subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia or neurological illness;
- •allergic to any ingredient of vaccine or with allergy history to any vaccine;
- •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);
- •administration of immunoglobulins within 30 days prior to this study;
- •acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- •have a clearly diagnosed history of thrombocytopenia or other coagulopathy, which might cause contraindications for subcutaneous injection;
- •any serious chronic illness, acute infectious diseases, or respiratory diseases; severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- •any kind of infectious, purulent, or allergic skin diseases;
- •pregnant women and breastfeeding women;
- •inoculated with any vaccine within 14 days of the study;
- •any other factor that makes the investigator determines the subject is unsuitable for this study.
研究组 & 干预措施
experimental group
408 subjects from experimental group will be simultaneously administrated with one dose of IIV (0.5 ml) and one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
干预措施: IIV4 and PPV23 (Biological)
control group B
408 subjects from control group B will be only administrated with one dose of PPV23 (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
干预措施: PPV23 (Biological)
control group A
408 subjects from control group A will be only administrated with one dose of IIV (0.5 ml). Blood samples are collected before vaccination and one month (30 days) later.
干预措施: IIV4 (Biological)
结局指标
主要结局
Seroconversion rate (IIV4)
时间窗: Results obtained 1 month after vaccination
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
时间窗: Results obtained 1 month after vaccination
the rate of positive seroconversion against 23 pneumococcal serotypes
Geometric Mean Concentration (GMC) (IIV4)
时间窗: Results obtained 1 month after vaccination
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Geometric Mean Concentration (GMC) (PPV23)
时间窗: Results obtained 1 month after vaccination
GMCs of 23 pneumococcal serotypes
Seroconversion rate (IIV4)
时间窗: Baseline (before vaccination) results
the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate (PPV23)
时间窗: Baseline (before vaccination) results
the rate of positive seroconversion against 23 pneumococcal serotypes
Geometric Mean Concentration (GMC) (IIV4)
时间窗: Baseline (before vaccination) results
GMCs of influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Geometric Mean Concentration (GMC) (PPV23)
时间窗: Baseline (before vaccination) results
GMCs of 23 pneumococcal serotypes
次要结局
- adverse events following vaccination(0-1 month (30 days))