A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 566
- 主要终点
- Geometric mean titer to hepatitis B surface antigen at Month 7
研究概览
简要总结
Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce protection against the morbidity and mortality of acute hepatitis B virus infection, [2] reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
- •Born to mothers with documented negative test for HBsAg within 9 months prior to delivery
排除标准
- •Infant born to mother with no prenatal care
- •Known or suspected impairment of immunologic function
- •Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
- •Recent(<72 hours) history of febrile illness >/= 99.5 degrees F (>/= 37.5 degrees C) axillary or >/= 100.5 degrees F (>/= 38.1 degrees C) rectal
- •Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
- •Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
- •Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
- •Any infant who cannot be adequately followed for study visits during the course of the clinical study
- •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
研究组 & 干预措施
1
Modified Process Hepatitis B Vaccine
干预措施: Comparator: Modified process Hepatitis B Vaccine (Biological)
2
Recombivax HB™
干预措施: Comparator: RECOMBIVAX HB™ (Biological)
结局指标
主要结局
Geometric mean titer to hepatitis B surface antigen at Month 7
时间窗: 4 weeks Post Dose 3
次要结局
- Safety and tolerability including use of Vaccination Report Card(Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card))