Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age

Sanofi Pasteur, a Sanofi Company14 个研究点分布在 1 个国家目标入组 378 人开始时间: 2004年12月1日最近更新: 2014年2月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 378
试验地点: 14
主要终点: Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to <6 years of age.

详细描述

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

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: 9 Months 至 5 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.
•Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
•Able to attend all scheduled visits and to comply with all trial procedures

排除标准

•History of a serious chronic disease that could interfere with trial conduct or completion.
•Known or suspected impairment of immunologic function.
•Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
•History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
•Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
•Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
•Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
•Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
•Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
•Unable to attend one or more of the scheduled visits or to comply with the study procedures.
•Participation in another clinical trial in the 4 weeks preceding enrollment.
•Planned participation in another clinical trial during the present trial period.
•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.