NCT00693186已完成3 期
An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With Either HEXAVAC® or INFANRIX®-HEXA
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 7
- 主要终点
- Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
研究概览
简要总结
Primary objective:
- To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .
Secondary objectives:
- Additional immunogenicity assessments
- Standard safety assessment.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy child of 4 to 7 years of age of either gender,
- •Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
- •Informed consent form signed by the parent(s) or by the legal representative.
- •Parent(s) or legal representative able to understand and comply with the study procedures.
排除标准
- •Any recent (<=3 days) history of febrile illness prior to vaccination,
- •Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
- •History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
- •History or current close contact with known carriers of hepatitis B virus,
- •Prior known sensitivity/allergy to any component of the study vaccines,
- •Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
- •Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •Any immune impairment or humoral/cellular deficiency or depressed immunity,
- •Any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
- •Any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
- •Any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
- •Any recent (<=28 days) receipt of a live vaccine or scheduled administration through Visit 2
研究组 & 干预措施
2
Experimental
干预措施: Engerix B® 10 µg / 0.5 mL (Biological)
1
Experimental
干预措施: HBVaxPRO® 5 µg / 0.5 mL (Biological)
结局指标
主要结局
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
时间窗: 28 to 42 days
次要结局
未报告次要终点
研究者
研究点 (7)
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