NCT00465816已完成3 期
Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 611
- 试验地点
- 7
- 主要终点
- Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
研究概览
简要总结
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
详细描述
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
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
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol
- •A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine.
- •Written informed consent obtained from the subject/ from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Previously completed routine childhood vaccinations to the best of his/her/the parents'/guardians' knowledge.
- •If the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
排除标准
- •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.
- •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 a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
- •Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
- •Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
- •Previous vaccination with tetanus toxoid within the last month.
- •Previous vaccination with hepatitis A and/or hepatitis B vaccine.
- •Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening.
- •History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection.
- •Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- •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 dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •History of chronic alcohol consumption and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究组 & 干预措施
Nimenrix + Twinrix Group
Experimental
Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
干预措施: Nimenrix (Meningococcal vaccine 134612) (Biological)
Nimenrix + Twinrix Group
Experimental
Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
干预措施: Twinrix (Biological)
Nimenrix Group
Active Comparator
Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
干预措施: Nimenrix (Meningococcal vaccine 134612) (Biological)
Twinrix Group
Active Comparator
Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
干预措施: Twinrix (Biological)
结局指标
主要结局
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
时间窗: At 1 month after vaccination with Nimenrix vaccine (Month 1)
The rSBA titers were expressed as geometric mean titers (GMTs).
Number of Subjects Seroprotected for Hepatitis B
时间窗: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Number of Subjects Seroconverted for Hepatitis A
时间窗: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values(Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1))
- Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7(At 7 months after vaccination with Nimenrix (At Month 7))
- Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135(At 1 month after vaccination with Nimenrix vaccine (Month 1))
- Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values(Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1))
- Anti-Tetanus Toxoid (TT) Antibody Concentrations(Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1))
- Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value(Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1))
- Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination(During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses)
- Number of Subjects Reporting Any Solicited General Symptoms(During a 4-day period (Days 0-3) after each vaccine dose and across doses)
- Number of Subjects Reporting Any Rash(During the entire study (up to Month 7))
- Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations(Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1))
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7(At 7 months after vaccination with Nimenrix (At Month 7))
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7(At 7 months after vaccination with Nimenrix (At Month 7))
- Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value(Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7))
- IgG Anti-HBs Antibody Concentrations(Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7))
- Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination(During a 4-day period (Days 0-3) after Nimenrix vaccination)
- Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7(At 7 months after vaccination with Nimenrix (At Month 7))
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(Up to 1 month after each vaccine dose)
- Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses(During the entire study (up to Month 7))
- Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits(During the entire study (up to Month 7))
- Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations(Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7))
- Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value(Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7))
- Number of Subjects Reporting Any Serious Adverse Events (SAEs)(During the entire study (up to Month 7))
研究者
研究点 (7)
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