NCT01096056已完成1 期
Safety and Immunogenicity of GSK2186877A Candidate Seasonal Influenza Vaccine in Healthy Children 6 to 35 Months of Age.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Subjects Reporting Fever Grade 2 or Higher
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age.
This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.
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
- •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.
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 (drug or vaccine) 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 (seasonal or pandemic) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone >0.5 mg/kg of body weight, or equivalent. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •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 consumption of egg proteins.
- •History of any neurological disorders or seizures (including febrile convulsion).
- •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 (such as mild diarrhoea, mild upper respiratory infection) 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
Influenza vaccine GSK2186877A formulation 1 Group
Experimental
Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
干预措施: Influenza vaccine GSK2186877A formulation 1 (Biological)
Influenza vaccine GSK2186877A formulation 1 Group
Experimental
Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
干预措施: Fluarix (Biological)
Influenza vaccine GSK2186877A formulation 2 Group
Experimental
Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
干预措施: Influenza vaccine GSK2186877A formulation 2 (Biological)
Influenza vaccine GSK2186877A formulation 2 Group
Experimental
Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
干预措施: Fluarix (Biological)
结局指标
主要结局
Number of Subjects Reporting Fever Grade 2 or Higher
时间窗: Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
次要结局
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs(Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A)
- The Number of Subjects Seroprotected to HI Antibodies(At Day 0 and Day 42)
- Haemagglutination Inhibition (HI) Antibody Titers(At Day 0 and Day 42)
- The Number of Subjects Seropositive to HI Antibodies(At Day 0 and Day 42)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)(Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A)
- Duration of Solicited Local AEs(Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A)
- Duration of Solicited General AEs(Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A)
- Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)(Day 0 up to Month 7)
- The Number of Subjects Seroconverted to HI Antibodies(Day 42)
- HI Antibody Geometric Mean Fold Rise (GMFR)(Day 42)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs(Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A)
- Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)(Day 0 up to Month 7)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(Day 0 up to Month 7)
研究者
研究点 (2)
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