A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)

China National Biotec Group Company Limited3 个研究点分布在 1 个国家目标入组 600 人开始时间: 2020年11月11日最近更新: 2020年11月19日

适应症

试验速览

阶段: 4 期
发起方: China National Biotec Group Company Limited
入组人数: 600
试验地点: 3
主要终点: Seroconversion rate (DTaP)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

Group 1: sIPV + DTaP + HepA,
Group 2: sIPV only,
Group 3: DTaP only,
Group 4: HepA only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

详细描述

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).

Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

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: 18 Months 至 19 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
•Subjects aged 18-19 months old at the date of recruitment;
•With informed consent form (ICF) signed by parent(s) or guardian(s);
•Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
•Subjects have not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
•No less than 14 days since the last dose of vaccination;
•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;
•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;
•With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
•With any serious chronic illness, acute infectious diseases, or respiratory diseases;
•With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
•With any kind of infectious, purulent, or allergic skin diseases;
•With any other factor that makes the investigator determines the subject is unsuitable for this study.