Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 9
- 主要终点
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
研究概览
简要总结
The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
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 should be enrolled in the study.
- •Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
- •Written informed consent obtained from the subject.
- •No serological signs of hepatitis A or B infection at screening.
- •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 (drug or vaccine) 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.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.
研究组 & 干预措施
Engerix-B+Havrix Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
干预措施: Engerix™-B (Biological)
Engerix-B+Havrix Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
干预措施: HAVRIX™ (Biological)
Twinrix Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix™ (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.
干预措施: TWINRIX™ (Biological)
HB VAX PRO+Vaqta Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
干预措施: HB VAX PRO™ (Biological)
HB VAX PRO+Vaqta Group
Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.
干预措施: Vaqta™ (Biological)
结局指标
主要结局
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
时间窗: At Month 7
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
时间窗: At Month 7
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.
Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
时间窗: At Month 7 after Twinrix vaccination
Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.
次要结局
- Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Gender(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Age(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by BMI(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption(At Month 7)
- Number of Subjects With SAEs(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Anti-HAV and Anti-HBs Antibody Concentrations(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Gender(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Age(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by BMI(At Month 7)
- Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication(At Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition(At Month 7)
- Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen(At Month 12 (M12), Month 24 (M24) and Month 36 (M36))
- Number of Subjects With Serious Adverse Events (SAEs)(From Day 0 up to Month 7)
- Anti-HAV and Anti-HBs Antibody Concentrations(At Month 7)