Phase IV Immunogenicity and Safety Study of Different Immunization Schedules of Inactivated Hepatitis A Vaccine (HAV) and/ or Combined Hepatitis A and Hepatitis B Vaccine (HABV) in Healthy Chinese Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
研究概览
简要总结
The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants.
详细描述
This study is a randomized double-blind, single-center, phase IV clinical trial. The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants between 18 and 24 months old. The subjects were randomly assigned into 3 groups. Subjects in group 1 each received 2 doses of HAV with a 6-month interval (at day 0 and month 6); subjects in group 2 each received 1 dose of HAV at day 0 and 1 dose of HABV at month 6; subjects in group 3 each received 2 doses of HABV with a 6-month interval (at day 0 and month 6).
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
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants between 18 and 24 months old;
- •Have not received hepatitis A vaccine before;
- •Completed hepatitis B vaccine full immunization schedule;
- •Written consent of the guardian of each participant;
- •Exclusion Criteria of the First Injection:
- •History of allergy to vaccine(s), or history of serious adverse reaction to vaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;
- •Autoimmune disease or immunodeficiency;
- •Any acute disease that made the conditions of the person unsuitable for vaccination
- •Administration of any live attenuated vaccine within 14 days prior to the injection;
- •Administration of any subunit vaccine or inactivated vaccine within 7 days prior to the injection;
- •Administration of treatment of immunosuppressants (e.g., corticosteroid) within 1 month prior to the injection, or planning for such treatment during this study;
- •Body temperature > 37.0 °C before injection;
- •Based on the evaluation of the investigator, there was any other factor that indicating the person was unsuitable for this study;
- •Exclusion Criteria of the Second Injection:
- •Any acute infectious disease, body temperature > 38.5 °C or acute attacks of chronic diseases within 3 days prior to the second injection;
- •Administration of blood product or other investigational drug during this study;
- •Occurrence of adverse event at grade 3 or higher and the event was related to the first injection;
- •The investigator or the Ethic Committee decided that the subject should be excluded;
排除标准
- 未提供
结局指标
主要结局
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
时间窗: 7 months
The post-immunization SPR is the percent of participants with anti-HAV titers ≥ 20 mIU/mL at month 7. Anti-HAV titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
次要结局
- The Post-immunization Geometric Mean Concentration (GMC) of Hepatitis A Antibody (anti-HAV)(7 months)
- The Post-immunization SPR to Hepatitis B(7 months)
- Occurrence of Adverse Events (AEs)(7 months)
- The Post-immunization GMC of Hepatitis B Surface Antibody (HBsAb)(7 months)