A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Anti-HAV seroconversion rate at 4 weeks after the second vaccination
研究概览
简要总结
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
详细描述
The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).
This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
- •Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
- •Written informed consent obtained from the subject's legal representative (parents or representative)
- •Children who no health issues based on medical history and physical examination as judged by the investigator
- •Exclusion Criteria
- •Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
- •Uncontrolled epilepsy or neurological disorder
- •History of thrombocytopenia or has a risk of bleeding
- •History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
- •Severe acute or chronic infectious disease on the day of vaccination
- •Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
- •Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days)
- •Administration of any other vaccine within 4 weeks prior to Screening
- •Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
- •Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
- •Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
- •Ineligibility for participate in the study for other reasons as determined by the investigator
排除标准
- 未提供
结局指标
主要结局
Anti-HAV seroconversion rate at 4 weeks after the second vaccination
时间窗: At Visit 6 (7 months after Day 1: first vaccination)
Seroconversion: anti-HAV ≥ 20 mIU/mL after the second vaccination in subjects with anti-HAV \< 20 mIU/mL at baseline
次要结局
- GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination(At Visit 6 (7 months after Day 1: first vaccination))
- GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination(At Visit 6 (7 months after Day 1: first vaccination))