A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,327
- 试验地点
- 41
- 主要终点
- Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
研究概览
简要总结
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- •Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- •Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
- •Female subjects of childbearing potential must agree to take a pregnancy test.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
- •History of hypersensitivity to any vaccine.
- •History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrollment.
- •History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Pregnant or lactating female.
- •Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
研究组 & 干预措施
Fluarix Group
Subjects in this group received Fluarix™ and will be further stratified by 3 age groups
- 1:1 in 6 months to < 36 months
- 1:1 in 3 to < 5 years
- 3:1 in 5 to < 18 years
干预措施: Fluarix™ (Biological)
Fluzone Group
Subjects in this group received Fluzone and will be further stratified by 3 age groups
- 1:1 in 6 months to < 36 months
- 1:1 in 3 to < 5 years
- 3:1 in 5 to < 18 years
干预措施: Fluzone (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
时间窗: 21 or 28 days after last vaccine dose
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Number of Seroconverted Subjects
时间窗: 21 or 28 days after last vaccine dose
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine.
Number of Subjects Reporting Rare Serious Events
时间窗: Up to 6 months after vaccination
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.
次要结局
- Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)(Up to 6 months after vaccination)
- Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer(21 or 28 days after last vaccine dose)
- Number of Subjects Reporting Solicited Local and General Symptoms(During a 4-day follow-up period after each vaccination)
- Number of Seroprotected Subjects(Before (PRE) and 21 or 28 days after (POST) the last vaccine dose)
- Number of Subjects Reporting Unsolicited Adverse Events(Within 28 days following vaccination)