NCT01165242已完成2 期
Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,013
- 试验地点
- 33
- 主要终点
- Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
研究概览
简要总结
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, 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 that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
- •Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.
- •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 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 (defined as more than 14 days) 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.
- •Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
- •Previous vaccination with vaccine components within the last month.
- •History of meningococcal disease.
- •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 is demonstrated.
- •History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
- •History of any neurologic disorders, including Guillain-Barré Syndrome.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrollment.
- •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.
- •Child in care.
- •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 A
Experimental
Subjects were vaccinated with vaccine GSK134612 Lot A
干预措施: Meningococcal vaccine GSK 134612 (Biological)
Group B
Experimental
Subjects were vaccinated with vaccine GSK134612 Lot B
干预措施: Meningococcal vaccine GSK 134612 (Biological)
Group C
Active Comparator
Subjects were vaccinated with Menactra®
干预措施: Menactra® (Biological)
结局指标
主要结局
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies
时间窗: One month after vaccination (Month 1)
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
次要结局
- Number of Subjects With New Onset of Chronic Illness(es) (NOCI)(From Month 0 through Month 6)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31 days (Day 0-30) post-vaccination)
- Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value(Prior to (PRE) and one month after vaccination (Month 1))
- hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers(Prior to (PRE) and one month after vaccination (Month 1))
- Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies(One month after vaccination (Month 1))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From Month 0 through Month 6)
研究者
研究点 (33)
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