Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 6
- 主要终点
- Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
研究概览
简要总结
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.
This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.
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
- 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 their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
- •Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- •Healthy children, as established by medical history and clinical examination when entering the study.
- •Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- •Clinically or virologically confirmed influenza infection within six months preceding the study start.
- •Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •History of hypersensitivity to vaccines.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- •Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- •Child in Care.
研究组 & 干预措施
GSK 2340272A F1 Group
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
干预措施: Pandemic influenza vaccine GSK2340272A (Biological)
GSK 2340272A F2 Group
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
干预措施: Pandemic influenza vaccine GSK2340272A (Biological)
结局指标
主要结局
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
时间窗: At Day 42
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
时间窗: At Day 42
Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination 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. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
时间窗: At Day 42
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
时间窗: At Day 42
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
时间窗: At Day 42
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
次要结局
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Day 0 up to Month 11-12))
- Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies(At Days 0, 21, 42 and at Month 11-12)
- Number of Subjects With Vaccine Response for Serum Neutralising Antibodies(At Days 21, 42 and at Month 11-12)
- Number of Subjects With Any Medically-attended Events (MAEs)(During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12))
- Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)(During the entire study period (Day 0 up to Month 11-12))
- Titers for Serum Neutralising Antibodies(At Days 0, 21, 42 and at Month 11-12)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period after each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period after each dose and across doses)
- Number of Subjects With Normal/Abnormal Biochemical Levels(At Days 0, 21 and 42)
- Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies(At Days 0, 21, 42, and at Month 11-12)
- Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers(At Days 21, 42 and at Month 11-12)
- Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies(At Days 0, 21, 42 and at Month 11-12)
- Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers(At Days 21, 42 and at Month 11-12)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84))