NCT01349829已完成4 期
A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule
Crucell Holland BV6 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 6
- 主要终点
- Seroprotection at Month 1
研究概览
简要总结
This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.
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
- 18 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between (and including) 18 months to 47 months of age.
- •Written informed consent obtained from the parent/legal guardian of the subject.
- •Free of obvious health problems as established by medical history and/or clinical examination before entering the study
排除标准
- •Seropositive for anti-HAV antibodies (>=10 mIU/ml).
- •Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.
- •Inhaled and local steroids are allowed.)
- •Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
- •Previous vaccination against hepatitis A.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment
结局指标
主要结局
Seroprotection at Month 1
时间窗: Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)
次要结局
- Seroprotection at Month 6(Month 6)
- Seroprotection at Month 7(Month 7)
- Geometric Mean Concentrations (GMCs)(Month 7)
研究者
研究点 (6)
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