A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 540
- 主要终点
- The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
研究概览
简要总结
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female older adults greater than or equal to 50 years of age
排除标准
- •Any adult with a history of previous hepatitis B infection
- •A history of vaccination with any hepatitis B vaccine
- •Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
- •Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
- •Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
- •Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
- •Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
- •Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
- •Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
- •Pregnant women, nursing mothers, and women planning to become pregnant within the study period
- •Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
研究组 & 干预措施
1
RECOMBIVAX HB™
干预措施: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) (Biological)
2
Modified Process Hepatitis B Vaccine
干预措施: Comparator: Modified Process Hepatitis B Vaccine (Experimental) (Biological)
3
ENGERIX-B™
干预措施: Comparator: ENGERIX-B™ (currently licensed product) (Biological)
结局指标
主要结局
The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
时间窗: 7 months (1 month after third vaccination)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
次要结局
- The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)(7 months (1 month after third vaccination))
- The Total Number of Participants With One or More Injection-site Adverse Experiences(Days 1-5 After Any Vaccination)
- The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C(Day 1-5 After Vaccination)
- The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences(During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months))