NCT00735020已完成1 期
A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年6月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
研究概览
简要总结
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.
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
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment
排除标准
- •serious medical conditions
- •allergies to vaccine components, including but not limited to egg/chicken products
- •reduced immune function
- •recent use of immunosuppressive therapy
- •recent use of influenza vaccine
结局指标
主要结局
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
时间窗: 36 Days
次要结局
- To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine(36 Days)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
1 期
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy ParticipantsHealthyNCT06577337Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany49
已完成
1 期
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310HealthyNCT05702450Keymed Biosciences Co.Ltd240
尚未招募
1 期
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy AdultsRespiratory Syncytial Virus InfectionsNCT06287450Shenzhen Shenxin Biotechnology Co., Ltd200
已完成
1 期
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy AdultsBacillus Anthracis (Anthrax) InfectionNCT01263691Emergent BioSolutions105
已完成
1 期
Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent VaccineCondylomata AcuminataNCT02405520Jun Zhang145