Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 15
- 主要终点
- Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
研究概览
简要总结
Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
详细描述
This study will assess the long-term protection offered by the new meningococcal vaccine GSK 134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine GSK 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension study. No new subjects will be enrolled. The subjects will have a blood sample taken at 24, 36 and 48 months after primary vaccination.
At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood samples will be taken 1 and 12 months after the booster 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
- None
入排标准
- 年龄范围
- 12 Months 至 23 Months（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)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- •Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
排除标准
- •Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject's first visit.
- •History of meningococcal disease.
- •Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- •Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- •Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- •Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- •History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study
- •Hypersensitivity to latex.
- •Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- •Previous vaccination with any component of the vaccines within the last month.
- •History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of vaccination.
结局指标
主要结局
Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off
时间窗: At Month 24 post primary vaccination
The cut-off value for the assay was greater than or equal to (≥) 1:8, as measured at the GlaxoSmithKline (GSK) laboratory.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off
时间窗: At Month 48 post primary vaccination
The cut-off value for the assay was ≥ 1:8. The analysis of this endpoint was performed by GSK.
Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres
时间窗: At Month 48 post-primary vaccination
The cut-off value for the aasay was ≥ 1:8. The rSBA-MenA results for the Year 4 time point were obtained by re-testing the samples in parallel at Public Health England (PHE).
次要结局
- Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off(At Month 36 post-primary vaccination)
- Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off(At Month 48 post primary vaccination)
- Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations(At Month 48 post-primary vaccination.)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values(At 12 months (Month 60) post booster dose)
- Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values(At one month (Month 49) post booster dose)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off(At Month 24 post primary vaccination)
- hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres(At 12 months (Month 60) post booster dose)
- Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values(At Month 48 post-primary vaccination)
- Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations(At 12 months (Month 60) post booster dose)
- Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values(At 12 months (Month 60) post booster dose.)
- Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values(At 12 months (Month 60) post booster dose)
- Number of Subjects Reporting Any Solicited Local Symptoms(During the 8-day period (Days 0-7) after booster vaccination)
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres(At 12 months (Month 60) post booster dose)
- Number of Subjects Reporting Any Solicited General Symptoms(During the 8-day period (Days 0-7) after the booster vaccination)
- Number of Subjects Reporting Any Adverse Events (AEs)(During the 31-day period (Days 0-30) after booster vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(From month 49 to month 60)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off(At one month (Month 49) post booster dose)