Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 2
- 主要终点
- Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
研究概览
简要总结
Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.
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 HAB-160 study (NCT 00603252).
- •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 the vaccination.
排除标准
- •The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, 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.
研究组 & 干预措施
HB VAX PRO + Vaqta Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
干预措施: Vaqta (Biological)
HB VAX PRO + Vaqta Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
干预措施: HBVAXPRO (Biological)
Engerix + Havrix Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
干预措施: Havrix (Biological)
Engerix + Havrix Group
Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
干预措施: Engerix-B (Biological)
Twinrix Group
Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
干预措施: Twinrix (Biological)
结局指标
主要结局
Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
时间窗: One month after the challenge dose.
Anamnestic response was defined as : * for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL), * for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration.
Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies
时间窗: One month after the challenge dose.
Anamnestic response was defined as: * for initially seronegative subjects, antibody concentration greater than or equal the cut-off \[≥ 15 Milli-International Units per Milliliter (mIU/mL)\], * for initially seropositive subjects with pre-vaccination antibody, concentration \< 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration, * for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration.
次要结局
- Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination(Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year))
- Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations(Two weeks and one month after the challenge dose)
- Number of Subjects Reporting Solicited Symptoms(During the 4-day follow-up period after the challenge dose.)
- Number of Subjects Reporting Unsolicited Symptoms(During the 31-day follow-up period after the challenge dose.)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(During one month following the administration of the challenge dose)
- Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations(Prior to administration of challenge dose)