Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
研究概览
简要总结
In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology.
These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.
详细描述
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups.
This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 34 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study
- •For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
- •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 knowledge.
- •If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 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 within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
- •Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •For the MPS Group, vaccination against meningococcal disease after completion of study 102394
- •For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup).
- •Previous vaccination against tetanus within 30 days.
- •History of meningococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical.
- •A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
- •History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
- •Know hypersensitivity to any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- •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 active stage of the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •History of chronic alcohol consumption and/or drug abuse.
研究组 & 干预措施
Mencevax Primed Group
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
干预措施: Meningococcal vaccine GSK134612 (Nimenrix) (Biological)
Mencevax Naive Group
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
干预措施: Meningococcal vaccine GSK134612 (Nimenrix) (Biological)
结局指标
主要结局
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
时间窗: One month post-vaccination (Month 1)
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
次要结局
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0 to Day 3) period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0 to Day 3) period after vaccination)
- Meningococcal rSBA Titers(Prior to vaccination (Day 0))
- Number of Subjects Reporting Any Serious Adverse Events(Day 0 to study month 6)
- Anti-meningococcal Polysaccharide (PS) Antibody Concentrations(Prior to (Day 0) and one month post-vaccination (Month 1))
- Anti-tetanus Toxoid Antibody Concentrations(Prior to (Day 0) and one month post-vaccination (Month 1))
- Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y(One month post-vaccination (Month 1))
- Number of Subjects With Any Specific Adverse Events(Day 0 to study month 6)
- Number of Subjects With Unsolicited Symptoms(Up to one month post-vaccination (Month 1))