Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 6
- 主要终点
- Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
研究概览
简要总结
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.
详细描述
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
- •Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy children as established by medical history and clinical examination before entering the study.
- •Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- •Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any neurological disorders or seizures.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
- •Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- •Child in care.
- •Previous vaccination at any time with an H5N1 vaccine.
- •Medical history of physician-confirmed infection with a H5N1 virus.
研究组 & 干预措施
GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
干预措施: GSK Biologicals' investigational vaccine GSK1562902A (Biological)
GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
干预措施: GSK Biologicals' investigational vaccine GSK1562902A (Biological)
GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
干预措施: GSK Biologicals' investigational vaccine GSK1562902A (Biological)
结局指标
主要结局
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
时间窗: At Day 192
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
时间窗: At Day 192
A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
时间窗: At Day 192
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
次要结局
- Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182 and Day 364)
- Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 0, Day 182, Day 192 and Day 364)
- Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain(At Day 0, Day 42, Day 182, Day 192 and Day 364)
- Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain(Day 182 and Day 364)
- Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182, Day 192 and Day 364)
- Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain(At Day 0, Day 182, Day 192 and Day 364)
- Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain(At Day 0, Day 42, Day 182, Day 192 and Day 364)
- Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005(At Day 0, Day 42, Day 182, Day 192 and Day 364)
- Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
- Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 182 and Day 364)
- Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
- Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
- Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
- Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(Day 0, Day 182, Day 192 and Day 364)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189))
- Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(Day 0, Day 42, Day 182, Day 192 and Day 364)
- Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(Day 0, Day 42, Day 182, Day 192 and Day 364)
- Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain(At Day 42, Day 182, Day 192 and Day 364)
- Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 182, Day 192 and Day 364)
- Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain(At Day 192 and Day 364)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to 364))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189))
- Number of Subjects With Potential Immune-mediated Disease (pIMDs)(During the entire study period (from day 0 to Day 364))
- Number of Subjects With Medically-attended Events (MAEs)(During the entire study period (from Day 0 to Day 364))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203))