A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 860
- 主要终点
- Number of Participants with Seroprotection to Hepatitis B Surface Antigen
研究概览
简要总结
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In general good health
- •Female participants have a negative pregnancy test just prior to vaccination on Day 1
排除标准
- •History of Hepatitis B Infection or vaccination
- •Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
- •Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
- •Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
- •Participation on prior study using an investigational drug or vaccine in prior 3 months
- •Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
- •Pregnant or nursing women or women planning to become pregnant within the study period
研究组 & 干预措施
V232 Modified Process Hepatitis B Vaccine: Lot A
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
干预措施: V232 Modified Process Hepatitis B Vaccine: Lot A (Biological)
V232 Modified Process Hepatitis B Vaccine: Lot B
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
干预措施: V232 Modified Process Hepatitis B Vaccine: Lot B (Biological)
V232 Modified Process Hepatitis B Vaccine: Lot C
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
干预措施: V232 Modified Process Hepatitis B Vaccine: Lot C (Biological)
V232 Current Process Hepatitis B Vaccine
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
干预措施: V232 Current Process Hepatitis B Vaccine (Biological)
结局指标
主要结局
Number of Participants with Seroprotection to Hepatitis B Surface Antigen
时间窗: 1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
时间窗: 1 month after the third vaccination (Month 7)
次要结局
- Percentage of Participants with Fever (>=37.8°C, 100.0°F)(Up to 5 days after any vaccination)
- Percentage of Participants with an Adverse Experience(Up to 15 days after any vaccination)
- Percentage of Participants with an Injection-site Adverse Experience(Up to 15 days after any vaccination)
- Percentage of Participants with a Systemic Adverse Experience(Up to 15 days after any vaccination)