NCT00603252已完成4 期
Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 8
- 主要终点
- Anti-HAV immune response to the challenge dose
研究概览
简要总结
This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
详细描述
All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
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
- None
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •A male or female who completed the primary vaccination phase of the study.
- •Written informed consent obtained from the subject.
- •If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Pregnant or lactating female.
结局指标
主要结局
Anti-HAV immune response to the challenge dose
Anti-HBs antibody response to the challenge dose
次要结局
- Occurrence of all serious adverse events (SAEs) reported(Following the administration of the challenge dose)
- Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects(Two weeks and one month after the challenge dose)
- Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects(Two weeks and one month after the challenge dose)
- Occurrence and intensity of solicited local symptoms(In the 4-day follow-up period after the challenge dose)
- Occurrence, intensity and relationship of solicited general symptoms(In the 4-day follow-up period after the challenge dose)
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported(During the 31-day follow-up period after the challenge dose)
研究者
研究点 (8)
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