Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine
2014年8月19日 更新者：Crucell Holland BV
A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine
The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.
研究概览
详细说明
Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose.
The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules.
A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented.
To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
研究类型
介入性
注册 (实际的)
84
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Antwerp、比利时、2610
- Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy male and female adults
- Aged ≥ 18 to ≤ 50 years on the day of enrollment
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
Exclusion Criteria:
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Body weight below 40 kg at any visit during the study
- Acute febrile illness (≥ 38.0°C)
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
- Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
- History of egg protein allergy or severe atopy
- Known blood coagulation disorder
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥ 0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, HIV seropositivity) or cancer
- Known history of psychiatric diseases, particularly dementia
- Investigational medicinal product received in the past 3 months (90 days)
- Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- Pregnancy or lactation
- Participation in another clinical trial for the entire duration of this trial
- Employee at the investigational site or relative of the investigator
- Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group 1
1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
其他名称：
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实验性的：Group 2
1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
其他名称：
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实验性的：Group 3
1 x triple standard dose (1.5 mL) on Day 1
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of local and systemic solicited adverse events
大体时间：4 days after each vaccination (day of vaccination and the followoing 3 days)
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4 days after each vaccination (day of vaccination and the followoing 3 days)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence of unsolicited AEs
大体时间：4 weeks after each vaccination
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4 weeks after each vaccination
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Humoral and cellular immune response against homologous and heterologous vaccine strains
大体时间：Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
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Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
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Incidence of SAEs
大体时间：up to 12 months after baseline
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up to 12 months after baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Enza di Modugno、Crucell Holland
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年6月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2012年5月10日
首先提交符合 QC 标准的
2012年6月8日
首次发布 (估计)
2012年6月12日
研究记录更新
最后更新发布 (估计)
2014年8月20日
上次提交的符合 QC 标准的更新
2014年8月19日
最后验证
2014年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.