Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Japanese Children Aged 6 Months to 17 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Seroprotected Subjects for HI Antibodies
研究概览
简要总结
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.
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 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.
- •Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.
- •Written informed consent obtained from the subject's parent(s) or LAR(s) of the subject. Whenever possible, an assent should also be obtained from the subject.
- •Healthy children as established by medical history and clinical examination when entering into the study (Particular attention must be exercised when dealing with patients with bronchial asthma).
- •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.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) 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 from May 2009 to the day of enrolment.
- •Previous administration of a novel [H1N1]v vaccine.
- •Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
- •Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day
- •Excessive underweight or excessive obesity. (Under or upper 2-fold standard deviation of weight distribution that are corresponding age group are used as reference).
- •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:
- •Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •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 known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- •History of any neurological disorder including acute disseminated encephalomyelitis and Guillain-Barré syndrome, or convulsive seizures and epilepsy.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible
- •Any conditions which, in the opinion of the investigator, prevents the subject from participating to the study.
- •Child in Care.
研究组 & 干预措施
GSK2340274A_F1 6M-9Y GROUP
Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
干预措施: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) (Biological)
GSK2340274A_F2 10Y-17Y GROUP
Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
干预措施: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) (Biological)
结局指标
主要结局
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 hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value
时间窗: At Day 42
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
时间窗: At Day 42
Titers are 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, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Number of Seroconverted Subjects for HI Antibodies
时间窗: At Day 42
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease
时间窗: At Day 42
GMFR, also called seroconversion factor (SCF), 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, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.
次要结局
- Number of Subjects With HI Antibody Concentrations Above the Cut-off Value(At Days 0 and 182)
- SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Day 182)
- Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1(At Day 182)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Up to 84 days (Days 0-83) after the first vaccination)
- Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Day 21)
- Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease(At Days 0 and 182)
- 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 Potential Immune-Mediated Diseases (pIMDs)(During the entire study period (from Day 0 to Day 182))
- Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease(At Days 0 and 182)
- Number of Seroconverted Subjects for HI Antibodies(At Day 182)
- Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value(At Days 0 and 182)
- Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1(At Day 21)
- Number of Subjects With Medically Attended Events (MAEs)(During the entire study period (from Day 0 to Day 182))
- Number of Seroprotected Subjects for HI Antibodies(At Days 0 and 182)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Day 182))
- Number of Subjects With Normal or Abnormal Biochemical Levels(At Days 0, 7 and 42)
- Number of Subjects With Normal or Abnormal Values of Haematological Parameters(At Days 0, 7 and 42)
- 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)