NCT01355172已完成4 期
Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- HA antibody titers will be determined using the WHO HAI reference technique.
研究概览
简要总结
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;
- •Subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
- •Subject must be in good physical health on the basis of medical history, physical examination;
- •Subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.
排除标准
- •Subjects had received influenza vaccine;
- •History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- •Personal or family history of Guillain- Barre' Syndrome;
- •An acute febrile illness within 1 week prior to vaccination;
- •Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
- •Subjects with influenza-like illness as defined by the presence of fever (temperature >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- •Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
- •History of wheezing or bronchodilator use within 3 months prior to study vaccine;
- •Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- •Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
- •Receipt of any blood products, including immunoglobulin in the prior 3 months;
- •Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
结局指标
主要结局
HA antibody titers will be determined using the WHO HAI reference technique.
时间窗: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.
次要结局
- The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.((4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination.)
研究者
研究点 (2)
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