NCT00649883已完成2 期
A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
研究概览
简要总结
This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to <60 months.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of 6 to <60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
- •In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
- •Able to comply with all study procedure
排除标准
- •Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
- •History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
- •Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
- •Bleeding diathesis;
- •Surgery planned during the study period;
- •Receipt of another investigational agent within 90 days
- •Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
- •Ever received two doses of an influenza vaccine before the study
- •Receipt of an influenza vaccine within 6 months prior to Visit 1;
- •Experienced a temperature 38.0°C within 3 days prior to Visit 1
结局指标
主要结局
To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
时间窗: 211 days
次要结局
- To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.(211 days)
研究者
研究点 (5)
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