Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 793
- 试验地点
- 90
- 主要终点
- Anti-PT, Anti-FHA and Anti-PRN Concentrations
研究概览
简要总结
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
Multicentre study with 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.
For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.
For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after 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 parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 12 and 23 months of age at the time of the first 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.
- •Documented three-dose primary vaccination with DTPa, hepatitis B, inactivated polio and Haemophilus influenzae type b conjugate vaccines, completed at least 180 days before administration of the first study vaccination.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first 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 first vaccine dose.
- •Planned administration/ administration of any vaccine not foreseen by the study protocol, including measles, mumps, rubella, varicella and pneumococcal vaccines, within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
- •Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W and/or Y.
- •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W and/or Y.
- •Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis or Haemophilus influenzae type b.
- •History of meningococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- •History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •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.
- •Additional criteria for subjects receiving Infanrix hexa™
- •Hypersensitivity reaction due to previous vaccination with Infanrix hexa™.
- •Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
研究组 & 干预措施
Group B
Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™
干预措施: Meningococcal vaccine GSK134612 (Biological)
Group A
Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™
干预措施: Meningococcal vaccine GSK134612 (Biological)
Group A
Meningococcal vaccine GSK134612 co-administered with Infanrix hexa™
干预措施: Infanrix™ hexa (Biological)
Group B
Meningococcal vaccine GSK134612 followed one month later by Infanrix hexa™
干预措施: Infanrix™ hexa (Biological)
Group C
Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612
干预措施: Meningococcal vaccine GSK134612 (Biological)
Group C
Infanrix hexa™ followed one month later by Meningococcal vaccine GSK134612
干预措施: Infanrix™ hexa (Biological)
Group D
Meningitec™ vaccination
干预措施: Meningitec™ (Biological)
结局指标
主要结局
Anti-PT, Anti-FHA and Anti-PRN Concentrations
时间窗: 1 month after the first vaccination (Month 1)
The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off
时间窗: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).
Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off
时间窗: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was ≥ 1μg/mL.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off.
时间窗: 1 month after vaccination with Nimenrix vaccine (Month 1)
The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values(At month 0, month 1 and month 2)
- Numbers of Seroprotected Subjects for Anti-PRP ≥ the Cut-off(At month 0, month 1 and month 2)
- Number of Seroprotected Subjects for Anti-HBs ≥ the Cut-offs(At month 0, month 1 and month 2)
- Anti-HBs Antibody Concentrations(At month 0, month 1 and month 2)
- Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations(At month 0, month 1 and month 2)
- Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT)(At month 0, month 1 and month 2)
- Number of Subjects Seroprotected for Anti-polio Type 1, 2 & 3 ≥ the Cut-off(At month 0, month 1 and month 2)
- Anti-PRP Antibody Concentrations(At month 0, month 1 and month 2)
- Number of Subjects Reporting Any Rash(Day 0 - Month 7)
- Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations(At month 0, month 1 and month 2)
- Anti-diphtheria (Anti-D) Antibody Concentrations(At month 0, month 1 and month 2)
- Anti-polio Type 1, 2 & 3 Titers(At month 0, 1 and 2)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-combined Diphtheria Vaccination(During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination)
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers(At month 0, month 1 and month 2)
- Number of Subjects With a Vaccine Response to PT, FHA and PRN Antigens(1 month after vaccination (Month 1))
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At month 0, month 1 and month 2)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination(During the 4-day (Days 0-3) follow-up period after Nimenrix or Meningitec vaccination)
- Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off(At month 0, month 1 and month 2)
- Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off(At month 0, month 1 and month 2)
- Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits (ER)(Day 0 - Month 7)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the Second Dose(Occurring within Day 0-30 following vaccination)
- Number of Subjects Reporting Any Solicited General Symptoms Following Each Dose(During the 4-day (Days 0-3) post-vaccination dose 1 (D1) and second dose (D2))
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First Dose(Occurring within Day 0-30 following vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(From dose 1 (Month 0) up to study end (Month 7))
- Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)(Day 0 - Month 7)