A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 主要终点
- Percentage of Seroresponders Before and After the Challenge Vaccination
研究概览
简要总结
The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •In general good health based on a medical history.
- •Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.
排除标准
- •Known history of previous Hepatitis B infection.
- •History of vaccination with any Hepatitis B vaccine within the last 2 years.
- •History of febrile illness.
- •Known or suspected hypersensitivity to any component of HBVaxPro.
- •Receipt of medication / vaccine that may interfere with study assessments.
- •Known or suspected immune impairment.
- •Pregnant women and nursing mothers.
研究组 & 干预措施
Modified Process Hepatitis B Vaccine in Base Study
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
干预措施: Modified Process Hepatitis B Vaccine (Biological)
ENGERIX-B™ Vaccine in Base Study
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
干预措施: Modified Process Hepatitis B Vaccine (Biological)
结局指标
主要结局
Percentage of Seroresponders Before and After the Challenge Vaccination
时间窗: Predose (Day 1) and 1 month after challenge dose (Month 1)
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
次要结局
- Percentage of Participants With One or More Systemic Adverse Experiences(Up to Day 15 after challenge dose)
- Percentage of Participants With One or More Serious Adverse Experiences(Up to Month 1 after challenge dose)
- Percentage of Participants Who Discontinued the Study Due to an Adverse Experience(Up to Month 7)
- Percentage of Participants With One or More Injection-site Adverse Experiences(Up to Day 15 after challenge dose)
- Percentage of Participants With One or More Adverse Experiences(Up to Day 15 after challenge dose)