A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,738
- 试验地点
- 1
- 主要终点
- Seroconversion rate for subjects in Stratum 2
研究概览
简要总结
The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.
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
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Three types of subject:
- •Neonates whose mothers are positive for both HBsAg and HBeAg
- •Neonates whose mothers are positive for only HBsAg
- •Neonates whose mothers are negative for both HBsAg and HBeAg
- •INCLUSION CRITERIA:
- •Full-term neonates with gestational age from 37 weeks to 42 weeks;
- •Apgar scores are no less than 7 at birth;
- •Neonates with standard body temperature (auxiliary temperature < 37.1°);
- •Neonates weighing ≥ 2,500 grams at birth;
- •Neonates with icteric index within the normal range (physiologic jaundice is permitted);
- •Informed consent form signed by parent/guardian;
- •The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.
排除标准
- •Subject's parent has a history of family diseases such as convulsion and brain diseases;
- •Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
- •Subject's parent is allergic to any composition of Hepatitis B vaccine;
- •A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
- •Known immunologic function damage;
- •Mothers had received gamma globulin or immunoglobulin injection during pregnancy;
- •Any congenital malformation
- •Known or suspected to suffer from diseases such as active infection and cardiovascular disease;
- •Any condition believed by the investigator to have possible impact on trial evaluation.
结局指标
主要结局
Seroconversion rate for subjects in Stratum 2
时间窗: Month 7
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.
Positivity for HBsAg for subjects in Stratum 1
时间窗: Month 2, Month 7 and Month 12
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
次要结局
- Seroconversion rate for subjects in Stratum 1(Month 12)
- Solicited adverse events(Days 1 to 4)
- Positivity for HBsAg for subjects in Stratum 2(Months 2, 7 and 12)