A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 2,719
- 试验地点
- 41
- 主要终点
- Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
研究概览
简要总结
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
排除标准
- •History of serious disease.
- •History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- •Known or suspected impairment/alteration of immune function.
- •Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- •Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- •For additional entry criteria, please refer to protocol.
结局指标
主要结局
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
时间窗: 21 days after each vaccination
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
时间窗: 21 days after each vaccination
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
次要结局
- Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age(21 days after each vaccination)
- Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age(21 days after each vaccination)
- Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age(7 days after vaccination)
- Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age(7 days after vaccination)
- Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age(7 days after vaccination)
- Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age(21 days after each vaccination)
- Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age(21 days after vaccination)
- Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age(7 days after vaccination)