The Phase Ⅳ Clinical Trial to Evaluate the Safety, Immunogenicity, and Immune Persistence of Three Consecutive Lots of an Inactivated Hepatitis A Vaccine in Healthy Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Anti-HAV titer
研究概览
简要总结
A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).
Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.
详细描述
The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.
Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.
After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health children from 1 to 10 years
- •Not participate in any other trial during the course of the trial
- •Informed consent
排除标准
- •Any history of allergic reactions or convulsions following vaccination
- •Other known or planned vaccination within 1 month prior to the study and during the study period
- •Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
- •Presence of any congenital abnormality, upgrowth obstacle
- •Any history/suspicion/presence of neurology and Lunacy
- •Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
- •Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
- •Abnormal ALT
- •Positive markers for anti-HAV and HBV（HBsAg）infection
- •Presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.
结局指标
主要结局
Anti-HAV titer
时间窗: 7 months after the first dose
To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.
次要结局
- Solicited adverse reactions (AE): local reactions and systematic reactions(72 hours after each injection)
- Unsolicited adverse reactions (AE)(7 months after the first dose)
- Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate(baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose)