A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (Containing Both Interpandemic Strains and H5N1) in Adults Aged 18 Years and Above
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 2
- 主要终点
- To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.
研究概览
简要总结
Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (aged 18 years and above) who have signed an informed consent form
排除标准
- •Any acute or chronic illness
- •Receipt of seasonal influenza vaccine for the current season 2007/2008
- •Known or suspected impairment/alteration of immune function
- •Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
- •Any serious disease
- •Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
- •Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination
研究组 & 干预措施
T/P-A
One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
干预措施: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine (Biological)
A/P-T
One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22.
干预措施: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1 (Biological)
A/S-A
One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22.
干预措施: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine (Biological)
T/P-A (V2 blood draw)
One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by a blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.
干预措施: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine (Biological)
A/P-T (V2 blood draw)
One dose of the Aflunov(A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by additional blood draw at visit 2 (V2) prior to the Tetravalent influenza vaccination (T) on day 22.
干预措施: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1 (Biological)
A/S-A (V2 blood draw)
One dose of Aflunov (A)and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed by an additional blood draw at visit 2 (V2) prior to Aflunov (A) vaccination on day 22.
干预措施: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine (Biological)
结局指标
主要结局
To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.
时间窗: up to day 43
The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence. The statistical analysis was done based on the GMRs.
次要结局
- Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination(Up to 7 days after 2nd vaccination)
- Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2(Up to 43 days)
- Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit(Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43))
- Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination(Up to 7 days after 1st vaccination)
- Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain(up to day 43)
- Antibody Response Determined by HI and MN Assay.(Up to 43 days)
- Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.(7 days after 1st and 2nd vaccinations each)
- Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.(Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43))