A Randomized, Double-blind, Multi-center, Active Controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Youths Above 16 Years or Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 12
- 主要终点
- Seroconversion rate
研究概览
简要总结
The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.
详细描述
For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 16 years or older on the day of the first vaccination
- •No history of hepatitis A or having hepatitis A vaccination
- •Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
- •Determined by the investigator to be able to be followed up during the study period
排除标准
- •A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
- •Positive hepatitis type B antigen at the time of screening
- •The following blood test results at the time of screening
- •ALT: More than 1.5 times the upper limit of normal
- •AST: More than 1.5 times the upper limit of normal
- •Total bilirubin: More than 1.5 times the upper limit of normal
- •Tympanic temperature of 38°C or above within 48 hours prior to the vaccination or on the day of vaccination
- •Moderate to severe acute or chronic infectious disease on the day of vaccination
- •History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
- •Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
- •Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
- •uncontrolled epilepsy or neurological disorders
- •Administered with other vaccine within 4 weeks prior to the screening
- •Planned with other vaccine within 4 weeks after the vaccination date
- •Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
- •Participated in another clinical study within 12 weeks prior to the screening, or currently participating
- •Pregnant women or breast-feeding women
- •Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study
研究组 & 干预措施
inactivated hepatitis A vaccine
Inactivated hepatitis A virus antigen 500U(Name of viral strain: TZ84)
干预措施: inactivated hepatitis A vaccine (Biological)
Havrix Inj
1440 ELISA/mL_Adult Inj.(Name of Viral strain: HM175 Inj)
干预措施: Havrix Inj (Biological)
结局指标
主要结局
Seroconversion rate
时间窗: 1 month after the second vaccination
Seroconversion criteria: Anti-HAV 20 IU/L or above
次要结局
- Seroconversion rate(1 month after the first vaccination)