Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Number of Seropositive Subjects for HI Antibodies
研究概览
简要总结
The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（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 3 and 9 years 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.
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.
- •Have received any seasonal flu vaccine since last year.
- •Previous administration of any H1N1 A/California-like vaccine
- •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. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •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:
- •Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •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
GSK2340272A F1 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
GSK2340272A F1 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
GSK2340272A F2 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
GSK2340272A F2 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
GSK2340272A F3 Y3-5 GROUP
Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
GSK2340272A F3 Y6-9 GROUP
Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
干预措施: GSK pandemic vaccine GSK2340272A (Biological)
结局指标
主要结局
Number of Seropositive Subjects for HI Antibodies
时间窗: At Day 42
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroconverted Subjects in Terms of HI Antibodies
时间窗: At Day 42
Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
时间窗: At Day 42
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects for HI Antibodies
时间窗: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
时间窗: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
次要结局
- Number of Seropositive Subjects for HI Antibodies(At Day 0, Day 21 and Month 7)
- Number of Seroprotected Subjects for HI Antibodies(At Day 0, Day 21 and Month 7)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- HI Antibody Titers Against Vaccine H1N1 Antigen(At Day 0, Day 21 and Month 7)
- Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer(At Day 21 and Month 7)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 12))
- Number of Subjects With Any Medically-attended Events (MAEs)(During the entire study period (from Month 0 up to Month 12))
- Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)(During the entire study period (from Month 0 up to Month 12))
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within the 42-day (Days 0-41) post-vaccination period)
- Number of Seroconverted Subjects in Terms of HI Antibodies(At Day 21 and Month 7)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)