Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,345
- 试验地点
- 20
- 主要终点
- Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
研究概览
简要总结
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.
Primary Objective:
To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.
Secondary Objective:
To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy as determined by medical history and physical examination.
- •Aged ≥ 11 to 17 years at the time of study vaccination on Day
- •Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
- •Informed assent form that has been approved by the IRB signed by the subject.
- •Subject (female) agrees to use measures to prevent pregnancy during the study.
排除标准
- •Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
- •Known or suspected impairment of immunologic function.
- •Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
- •History of documented invasive meningococcal disease or previous meningococcal vaccination.
- •History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
- •Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
- •Received antibiotic therapy within the 72 hours prior to vaccination on Day
- •Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
- •Suspected or known hypersensitivity to either of the two study vaccines or their components.
- •Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
- •Enrolled in another clinical trial.
- •Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- •For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
- •Nursing mothers.
研究组 & 干预措施
Study Group A
Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
干预措施: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (Biological)
Study Group B
Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later
干预措施: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (Biological)
Study Group C
Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later
干预措施: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap (Biological)
结局指标
主要结局
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
时间窗: Day 0 to Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
时间窗: Day 0 and Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
时间窗: Day 0 and Day 28 Post-vaccination
次要结局
- Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.(0 to 7 days post-vaccination)