NCT00731393已完成3 期
To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 14
- 主要终点
- GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
研究概览
简要总结
The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.
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
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- •Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
- •All children included in the study must never have been given a prophylactic influenza inoculation.
- •Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an 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 until 30 days after administration of the second vaccine dose.
- •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.
- •Known allergic reactions that might have been caused by one or more components of the vaccine.
- •Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.
结局指标
主要结局
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
时间窗: On Day 21 (+- 2) after the second vaccination
次要结局
- Descriptive comparison of the occurrence and severity of solicited local and general symptoms(Within 4 days after each vaccination)
- Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms(Within 30 days after each vaccination)
- Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).(Throughout the study)
- GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.(On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination)
研究者
研究点 (14)
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