Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 882
- 试验地点
- 26
- 主要终点
- Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.
The main objectives are:
Immunogenicity:
To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.
Safety:
To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
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
- 4 Years 至 7 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 4 to < 7 years at the time of study vaccination on Day
- •Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
- •Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.
排除标准
- •Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
- •Known or suspected impairment of immunologic function
- •Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
- •History of documented invasive meningococcal disease or previous meningococcal vaccination
- •Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
- •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 enrollment.
- •Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
- •Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
- •Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
- •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 physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- •Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
- •Personal or family history of Guillain-Barré Syndrome (GBS).
研究组 & 干预措施
Group 1
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
干预措施: Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Group 2
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
干预措施: Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Group 3
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
干预措施: Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
结局指标
主要结局
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
时间窗: Day 30 post-vaccination (Visit 1)
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
时间窗: Day 30 post-vaccination (Visit 1)
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
次要结局
- Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1(Day 30 post-vaccination 1)
- Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination(Day 30 post-vaccination)
- Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine(Day 0 through Day 7 post-vaccination at Visit 1)