Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,317
- 试验地点
- 70
- 主要终点
- Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female child aged 6 to 35 months at the time of the first 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.
- •Written informed consent obtained from the subject's parent/guardian.
排除标准
- •Use of any investigational or non-registered product (drug or 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 criterion.
- •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 enrolment.
- •History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- •Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
- •Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
研究组 & 干预措施
Fluarix Dose A Group
Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
干预措施: Fluarix (Biological)
Fluarix Dose B Group
Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
干预措施: Fluarix (Biological)
Fluzone Group
Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).
* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
干预措施: Fluzone (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
时间窗: Day 0 (PRE), Day 28 or Day 56 (POST)
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Number of Subjects Who Seroconverted
时间窗: Day 28 or Day 56
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
次要结局
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During a 28-day follow-up period after vaccination)
- Seroconversion Factor(Day 28 or Day 56)
- Number of Subjects Reporting Solicited Local Symptoms(During a 4-day follow-up period after vaccination)
- Number of Subjects Reporting Solicited General Symptoms(During a 4-day follow-up period after vaccination)
- Number of Seroprotected Subjects(Day 0 (PRE), Day 28 or Day 56 (POST))
- Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)(During the entire study (Day 0 until Month 6))
- Number of Subjects Reporting Rare Serious Events(During the entire study (Day 0 until Month 6))