Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 13
- 主要终点
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.
详细描述
The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.
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, Care Provider, 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
- •Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •A 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.
- •Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
- •Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
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 study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
- •Child in care.
- •Chronic administration 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/day, or equivalent. Inhaled and topical steroids are allowed.
- •Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- •History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
- •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.
- •Acute disease and/or fever at the time of enrollment.
- •Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
研究组 & 干预措施
FluLaval Quadrivalent Group
Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
干预措施: FluLaval® Quadrivalent (Biological)
Fluzone Group
Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
干预措施: Fluzone® (Biological)
结局指标
主要结局
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
时间窗: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
次要结局
- Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.(28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects))
- Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains(On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively))
- Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.(At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects))
- Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.(28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Fever(During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination)
- Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)(During the entire study period (Day 0 to Day 180))
- Duration of Solicited Local and General Symptoms(During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination)
- Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)(During the entire study period (Day 0 to Day 180))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 - Day 180))