A Phase 2, randomized, comparative, multicenter study evaluating the safety and immunogenicity of a new liquid formulation of adsorbed meningococcal C vaccine (conjugate CRM-197), a lyophilized meningococcal C vaccine (conjugate CRM-197) manufactured at a new site, and a lyophilized meningococcal C vaccine (conjugate CRM-197) in normal healthy toddlers

ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2011年7月7日最近更新: 2015年7月10日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Subjects eligible to be enrolled in the study:
•1.Healthy 12 – 23 (inclusive) month-old male or female toddlers
•2.A parent/legal guardian has given written informed consent after the nature of the study has been explained.
•3.Available for both the visits scheduled in the study.
•4.In good health as determined by medical history, physical examination and clinical judgment of the investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 979
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1.History of any meningococcal vaccine administration.
•2.Previous known or suspected disease caused by N. meningitidis.
•3.Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
•4.History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.
•5.Significant acute or chronic infection within the previous 7 days or axillary temperature =38.0°C within the previous 3 days.
•6.Individuals who have received antibiotics within 6 days before vaccination. .
•7.Known or suspected autoimmune disease or impairment/alteration of the immune system
•8.History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).
•9.Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
•10.Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
•11.Taken any antipyretic medication in the previous 6 hours.
•12. Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization).
•13.Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
•14.Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study.
•15.Family members or household members of site research staff.
•16.History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
•17.Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

研究者

发起方

ovartis Vaccines and Diagnostics S.r.l.

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