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)

China National Biotec Group Company Limited4 个研究点分布在 1 个国家目标入组 1,224 人2020年9月11日

适应症Influenza, Human Pneumonia, Pneumococcal

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: Influenza, Human
发起方: China National Biotec Group Company Limited
入组人数: 1224
试验地点: 4
主要终点: Seroconversion rate (IIV4)
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

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. To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

注册库

clinicaltrials.gov

开始日期

2020年9月11日

结束日期

2021年10月9日

最后更新

3年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

China National Biotec Group Company Limited

责任方

Sponsor

入排标准

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;