NCT01154088已完成3 期
Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Mencevax™ ACWY in Healthy Subjects Aged 18-25 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
- 1,170
- 试验地点
- 4
- 主要终点
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
研究概览
简要总结
The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must satisfy all of the following criteria at study entry:
- •Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
- •A male or female between, and including, 18 and 25 years of age the time of the vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.
排除标准
- •The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed).
- •Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine, including H1N1 vaccine.
- •Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
- •Previous vaccination with meningococcal conjugate vaccine.
- •Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
- •History of meningococcal disease.
- •Seropositive for HIV or HBsAg (for subjects in the Philippines only).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 has been demonstrated.
- •History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
- •History of any neurologic disorders, including Guillain-Barré Syndrome.
- •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.
- •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
研究组 & 干预措施
Group C
Active Comparator
干预措施: Mencevax ACWY (Biological)
Group A
Experimental
干预措施: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] (Biological)
Group B
Experimental
干预措施: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] (Biological)
结局指标
主要结局
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
时间窗: At Month 1
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Number of Subjects With Vaccine Response for 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
时间窗: At Month 1
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
次要结局
- Number of Subjects With New Onset Chronic Illnesses (NOCI)(Within 31-days (Days 0-30) post-vaccination)
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers(At Day 0)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value(At Day 0 and at Month 1)
- Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies(At Month 1)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31-days (Days 0-30) post-vaccination)
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value(At Day 0 and Month 1)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 4-days (Days 0-3) post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 4-days (Days 0-3) post-vaccination)
研究者
研究点 (4)
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