Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers

Sanofi Pasteur, a Sanofi Company5 个研究点分布在 1 个国家目标入组 360 人开始时间: 2008年4月1日最近更新: 2018年2月6日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 360
试验地点: 5
主要终点: To provide information concerning the safety and immunogenicity after administration of TetraMenT

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

This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

Primary Objectives: Safety and Immunogenicity:

To describe the safety and immunogenicity profiles of:

A single dose of each formulation of TetraMen-T vaccine
A single dose of NeisVac-C® vaccine.

详细描述

The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.

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: 12 Months 至 12 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•Subject is healthy, as determined by medical history and physical assessment.
•Aged 12 months (± 21 days) on the day of inclusion.
•Institutional Review Board (IRB)-approved informed consent form signed by the subject's parent/legal guardian.
•Able to attend all scheduled visits and to comply with all trial procedures.

排除标准

•Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
•Known or suspected impairment of immunologic function.
•Acute medical illness within the last 72 hours, or temperature ≥ 37.5ºC (axillary) at the time of enrollment (temporary contraindication).
•History of documented invasive meningococcal disease or previous meningococcal vaccination.
•Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
•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 two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
•Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
•Suspected or known hypersensitivity to any of the vaccine components.
•Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
•Parent or legal guardian unable or unwilling to comply with the stu dy procedures.
•Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
•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.
•Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to 14 days before or 14 days after receiving the study vaccines.
•History of seizures, including febrile seizures, or any other neurologic disorder.
•Personal or family history of Guillain-Barré Syndrome (GBS).