Observer-blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Adjuvanted Quadrivalent Influenza Candidate Vaccines (GSK2584786A) in Children Aged 6 to 35 Months
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Serum Neutralizing Antibody Titers
研究概览
简要总结
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •All subjects must satisfy ALL the following criteria at study entry:
- •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] 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 the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
- •Born after gestation period of 36 to 42 weeks inclusive
排除标准
- •The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- •Child in "care"
- •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.
- •Prior receipt of any influenza vaccination or planned administration during the study period.
- •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 six months prior to the first vaccine dose.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •A family history of febrile seizures or/and epilepsy
- •Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to any constituent of influenza vaccine.
- •History of any progressive neurological disorders or seizures.
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- •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 without fever might be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- •Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
研究组 & 干预措施
GSK2321138A vaccine Group
Subjects received 2 doses of GSK Biologicals' non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
干预措施: GSK Bio's influenza vaccine GSK2321138A (Biological)
GSK2584786A vaccine 1 dose of Formulation A3 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
Fluarix Group
Subjects received 2 doses of Fluarix Vaccine.
干预措施: Fluarix™ (Biological)
GSK2584786A vaccine 1 dose of Formulation A2 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 1 dose of Formulation A1 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation A1 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation A2 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation A3 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 1 dose of Formulation B1 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation B1 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 1 dose of Formulation B2 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation B2 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 1 dose of Formulation B3 Group
Subjects received 1 dose of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
GSK2584786A vaccine 2 doses of Formulation B3 Group
Subjects received 2 doses of GSK Biologicals' adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
干预措施: GSK Bio's influenza vaccine GSK2584786A, different formulations (Biological)
结局指标
主要结局
Serum Neutralizing Antibody Titers
时间窗: at Day 28/ Day 56
Geometric Mean Number of All-CD4 Cytokine Positive Cells
时间窗: at Day 28/ Day 56
Geometric mean of the number of CD4 cytokine positive T cells per million T cells.
Number of Subjects Reporting Fever of at Least Grade 2 or Higher
时间窗: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine
Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.
Serum Haemagglutination-inhibition (HI) Antibody Titers
时间窗: at Day 28/ Day 56
Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.
次要结局
- Number of Subjects Reporting Potential Immune-mediated Diseases(From Day 0 to 179)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(within 28 days (Day 0 to Day 27) after any vaccination)
- Number of Subjects Reporting Adverse Events With Medically Attended Visits(From Day 0 to 179)
- Number of Subjects Reporting Serious Adverse Events(From Day 0 to 179)
- Serum HI Antibody Titers(on Days 0, 28/56 and 180)
- Serum Neutralising Antibody Titers(on Days 0, 28/56 and 180)
- Number of Subjects Reporting Solicited Local and General Symptoms(during a 7 day follow-up period (Day 0 to 6) after any vaccination)