EUCTR2006-001639-23-ES进行中（未招募）1 期
A Study to Assess the Anamnestic Immune Response 4 to 6 Years After a Primary Vaccination Series With HBVAXPRO™Estudio para evaluar la respuesta inmune anamnésica 4 a 6 años después de una pauta de vacunación completa con HBVAXPRO. - Hepatitis B Vaccine (Recombinant) Booster Study
Merck SHARP & DOHME DE ESPAÑA0 个研究点目标入组 1,478 人开始时间: 2006年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,478
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Healthy male and female children 4 to 6 years of age
- •?Complete medical records documenting the administration of a 3-dose series of HBVAXPRO™ or ENGERIX-B™ administered according to one of the following schedules: birth, 1, and 6 months of age; birth, 2, and 6 months of age; or 2, 4, and 6 months of age (for Cohorts A and B only).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Birth mother known to be a carrier of hepatitis B virus (HbsAg+) or known carriers ever living in close contact with the subject
- •?History of previous hepatitis B infection
- •?History of vaccination with any hepatitis B vaccine (Cohort C only)
- •?History of any hepatitis B vaccination after copmletion of he 3-dose primary series (Cohorts A and B only)
- •?A combination of different hepatitis B vaccines used in the primary vaccination series (Cohorts A and B only)
- •?Recent (<72 hours) history of febrile illness (oral temperature =37.8°C [=100.0°F])
- •?Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminum, yeast)
- •?Recent administration (within 3 months prior to study start) of hepatitis B immune globulin, or any other blood-derived product (excluding autologous product)
- •?Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
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