Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 12
- 主要终点
- Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
研究概览
简要总结
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.
Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
详细描述
Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
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
- 1 Year 至 10 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 or guardian can and will comply with the requirements of the protocol.
- •A male or female between, and including, 1 through 10 years of age at the time of vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
排除标准
- •For the primary phase:
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- •Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- •Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
- •History of meningococcal disease due to serogroup A, C, W, or Y.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •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.
- •For the long term persistence phase:
- •History of meningococcal serogroup A, C, W, and/or Y disease.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
研究组 & 干预措施
Group A
All subjects received GSK Biolgicals' meningococcal vaccine 134612.
干预措施: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) (Biological)
Group B
Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
干预措施: Mencevax™ ACWY (Biological)
Group B
Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
干预措施: Meningitec™ (Biological)
结局指标
主要结局
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
时间窗: One month after vaccination [PI(M1)]
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response
时间窗: One Month after vaccination
Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
时间窗: One month after vaccination [PI(M1)]
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
次要结局
- Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values(Prior to (PRE) and one month after vaccination [PI(M1)])
- Anti-PS Antibody Concentrations(Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)])
- Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value(Prior to (PRE) and one month after vaccination [PI(M1)])
- Anti-TT Antibody Concentrations(Prior to (PRE) and one month post vaccination [PI(M1)])
- Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value(Prior to (PRE) and one month after vaccination [PI(M1)])
- Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value(Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)])
- Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value(Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)])
- Number of Subjects With Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period)
- rSBA Antibody Titers(Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)])
- Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value(Prior to (PRE) and one month after vaccination [PI(M1)])
- Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value(Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)])
- Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value(Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)])
- Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value(Prior to (PRE) and one month after vaccination [PI(M1)])
- Number of Subjects With New Onset of Chronic Illnesses (NOCIs)(From administration of the vaccine dose until 6 months later)
- Number of Subjects With Anti-TT Antibody Concentrations(Prior to (PRE) and one month after vaccination [PI(M1)])
- Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value(Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)])
- Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value(Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)])
- Number of Subjects With Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period)
- Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit(From administration of the vaccine dose until 6 months later)
- Number of Subjects With Serious Adverse Events (SAEs)(Up to 6 Months after vaccination)
- Number of Subjects With Rash(From administration of the vaccine dose until 6 months later)
- hSBA Antibody Titers(Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)])
- rSBA Antibody Titers (HPA Laboratory Assay)(At Persistence Year 4 [PI(M48)])
- Number of Subjects With Unsolicited AEs(During the 31-day (Days 0-30) post-vaccination period)
- Number of Subjects With SAE(s)(From 6 Months following vaccination up to Year 5)