Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
研究概览
简要总结
This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
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
- Double (Participant, 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 who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
- •The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
- •Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.
排除标准
- •Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
- •Acute disease at the beginning of the study
- •Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
- •Pregnancy
- •Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
- •Known allergic reactions that might have been caused by one or more ingredients of the vaccine
研究组 & 干预措施
Group A
The subjects in this group will be 18-60 years.
干预措施: Thiomersal free trivalent influenza split vaccine 2002/2003 (Biological)
Group B
The subjects in this group will be > 60 years.
干预措施: Thiomersal free trivalent influenza split vaccine 2002/2003 (Biological)
Group C
The subjects in this group will be 18-60 years.
干预措施: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 (Biological)
Group D
The subjects in this group will be > 60 years.
干预措施: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 (Biological)
结局指标
主要结局
GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
时间窗: On Day 21 (± 2) after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
时间窗: Within 4 days after vaccination
次要结局
- Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms(Within 30 days after vaccination)
- Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)(During the entire study period.)
- Investigation of antibody persistence assessed by the criteria of the CHMP.(11, 19, 27 weeks after vaccination)