A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Occurrence of unsolicited adverse events
研究概览
简要总结
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence of unsolicited adverse events
时间窗: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
时间窗: At days 21, 42 and 180
Occurrence of serious adverse events
时间窗: During the entire study (Days 0 to 180)
To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
时间窗: At Days 0, 21, 42 and 180
Geometric mean titers (GMTs) of serum antibodies
Occurrence of solicited local and general adverse events
时间窗: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
次要结局
- To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers(At Days 0, 21, 42 and 180)
- To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes(At days 0, 21, 42 and 180)
- To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers(At Days 21, 42 and 180)