NCT00848887已完成1 期
A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 410
- 试验地点
- 2
- 主要终点
- Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
研究概览
简要总结
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.
排除标准
- •History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.
结局指标
主要结局
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
时间窗: 50 days
次要结局
- Strain-specific influenza antibody titers will be used to assess Immunogenicity(50 days)
研究者
研究点 (2)
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