Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
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 3 and 17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 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 17 years at the time of the first study vaccination.
- •Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- •Healthy children as established by medical history and clinical examination when entering into 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.
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.
- •Acute disease and/or fever at the time of enrolment
- •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.
- •Previous administration of any H1N1 A/California-like vaccine.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- •If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- •Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- •Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- •Child in Care.
研究组 & 干预措施
Group A
干预措施: Pandemic influenza vaccine GSK2340272A (Biological)
结局指标
主要结局
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
时间窗: At Day 0
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
Seroconversion Factor (SCF) for HI Antibody Titers
时间窗: At Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Titers for Serum HI Antibodies
时间窗: At Day 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
时间窗: At Day 42
A seroconverted subject was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 prior to vaccination\], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
时间窗: At Day 42
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
时间窗: At Day 42
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
次要结局
- Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies(At Month 12)
- Number of Subjects With Any Medically-attended Events (MAEs)(During the entire study period (from Day 0 up to Month 12))
- Number of Subjects With Normal or Abnormal Biochemical Levels(At Days 0, 21 and 42)
- 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)
- Number of Subjects With HI Antibody Concentrations Above the Cut-off Value(At Days 0, 21, 42 and at Month 12)
- Titers for Serum HI Antibodies(At Days 0, 21, 42 and at Month 12)
- Number of Seroprotected Subjects in Terms of HI Antibodies(At Days 0, 21, 42 and at Month 12)
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value(At Month 12)
- Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies(At Days 21, 42 and at Month 12)
- Seroconversion Factor (SCF) for HI Antibody Titers(At Days 21, 42 and at Month 12)
- Titers for Serum Neutralizing Antibodies(At Month 12)
- Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)(During the entire study period (from Day 0 up to Month 12))
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 up to Month 12))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination)
- 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)