NCT02012998已完成3 期
An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of 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
- 751
- 试验地点
- 10
- 主要终点
- Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
研究概览
简要总结
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy child
- •Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant
- •Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose
排除标准
- •Receipt of more than 3 doses of any Hepatitis B containing vaccine
- •History of clinical diagnosis of infection due to Hepatitis B
- •History or current close contact with known carriers of Hepatitis B virus
- •Prior known sensitivity or allergy to any component of HBVAXPRO
- •Chronic illness / medical condition that could interfere with study conduct or completion
- •Coagulation disorder that would contraindicate intramuscular injection
- •Subject is pregnant
- •Receipt of corticosteroids for more than 14 days in the 30 days prior to study
- •Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study
- •Planned participation in another clinical study
研究组 & 干预措施
HBVAXPRO Challenge dose
Experimental
HBVAXPRO 5µg
干预措施: HBVAXPRO 5µg (Biological)
结局指标
主要结局
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
时间窗: One month after the challenge dose
次要结局
- Serious adverse events(From signature of the informed consent to the last visit of the subject, an expected average of one month)
- Solicited injection-site adverse reactions and pyrexia(Day 0 to day 4 after vaccination)
- Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL(Prior to challenge dose (At Day 0 prior to administration of the challenge dose))
- Unsolicited injection-site adverse reactions and systemic adverse events(Day 0 to day 14 after vaccination)
研究者
研究点 (10)
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