JPRN-jRCT2080223345未知3 期
A Phase 3, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children age 2 years through 18 years
试验速览
- 阶段
- 3 期
- 入组人数
- 914
研究概览
简要总结
The incidence of symptoms of influenza infection and onset of influenza identified by testing to be due to any wild-type influenza virus regardless of antigen matching with vaccine strain was 25.5% (152/597) in the MEDI3250 group and 35.9% (104/290) in the placebo group. The relative risk reduction (95% CI) versus the placebo group was 28.8% (12.5-42.0), verifying the superiority of single vaccination with MEDI3250 over placebo in terms of preventing influenza onset in children 2 to <19 years old.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 <= 18age old（—）
- 性别
- All
入选标准
- •1) Healthy Japanese Children age 2 years through 18 years at the time of informed consent.
- •2) The ability of the subject to give to comply with study procedures and performed any study-specific procedure, to offer any symptom.
排除标准
- •1) Administration of any influenza virus vaccine within 6 months prior to informed consent.
- •2) Use of antiviral agents with activity against influenza virus within 28 days prior to informed consent.
研究者
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