NCT00915187已完成2 期
A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study
NasVax Ltd1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
研究概览
简要总结
To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
- •able to comply with all the study requirements;
- •in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
- •Have adequate renal function (renal clearance of at > 30ml/min)
- •Have normal liver function (hepatic transaminases [ALT and AST] < 43 U/L)
- •Have hemoglobin > 11.5 g/L
排除标准
- •Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
- •Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at < 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
- •Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
- •History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
研究组 & 干预措施
Control
Active Comparator
干预措施: Influenza Vaccine (Biological)
CCS/C (Adjuvant Formulation)
Experimental
干预措施: CCS/C (Drug)
结局指标
主要结局
Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
时间窗: Day 28 following vaccination
次要结局
- Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate(Day 90 following vaccination)
研究者
研究点 (1)
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