A Phase III, Single-Blind, Multi-Center, Extension Study to Evaluate Safety and Tolerability of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adult and Elderly Subjects Who Participated in Study V58P4, With Subset Analyses of Immunogenicity and Evaluation of Concomitant Polysaccharide Pneumococcal Vaccine (Elderly).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,522
- 试验地点
- 10
- 主要终点
- Number of Randomized Participants Reporting Local and Systemic Reactions.
研究概览
简要总结
The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.
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
- •participation in the V58P4 study
- •mentally competent to understand the nature, the scope and the consequences of the study
- •able and willing to give written informed consent prior to study entry
- •available for all the visits scheduled in the study
排除标准
- •receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study
- •history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components
- •any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit 7
- •pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
结局指标
主要结局
Number of Randomized Participants Reporting Local and Systemic Reactions.
时间窗: One week postvaccination
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Immunogenicity Assessment by Geometric Mean Titers (GMT).
时间窗: Three weeks postvaccination
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
次要结局
- Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.(Three weeks postvaccination)
- Number of Unrandomized Participants Reporting Local and Systemic Reactions.(One week postvaccination)
- Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.(Three weeks postvaccination)
- Number of Randomized Participants Reporting Local and Systemic Reactions.(One week postvaccination)