Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-label, Baseline-controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase
研究概览
简要总结
Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.
详细描述
An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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
- •Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- •Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
- •Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.
排除标准
- •Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- •A serious adverse reaction after a previous (influenza) vaccination.
- •Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- •Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
- •Having any condition which suppresses the immune system and autoimmune disorders.
结局指标
主要结局
Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase
时间窗: 3 weeks
Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.
Solicited local and systemic reactions, overall inconvenience
时间窗: 3 days
Reactogenicity and inconvenience
Unsolicited adverse events
时间窗: 3 weeks
Other adverse events
次要结局
未报告次要终点