A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,478
- 主要终点
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
研究概览
简要总结
To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Children 4 to 8 years of age
- •Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
- •Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)
排除标准
- •Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
- •History of previous hepatitis B vaccine
- •History of vaccination with any hepatitis B vaccine (Cohort C only)
- •Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
- •Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
- •Impairment of immunologic function or recent use of immunomodulatory medications
- •A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)
研究组 & 干预措施
5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)
Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study.
During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose).
干预措施: Comparator: Modified Process Hepatitis B Vaccine (Biological)
10 µg ENGERIX-B™ Booster (Group 2)
Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study.
During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose)
干预措施: Comparator: Comparator: ENGERIX-B (Biological)
5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)
Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study.
During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose).
干预措施: Comparator: Modified Process Hepatitis B Vaccine (Biological)
10 µg ENGERIX-B™ Booster (Group 4)
Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study.
During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose).
干预措施: Comparator: Comparator: ENGERIX-B (Biological)
5 µg Modified Process Hepatitis B Vaccine (Group 5)
Participants did not receive a prior vaccination with a hepatitis B vaccine.
During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine.
干预措施: Comparator: Modified Process Hepatitis B Vaccine (Biological)
结局指标
主要结局
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
时间窗: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
次要结局
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy(4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B)