EUCTR2004-005150-31-DE进行中（未招募）不适用
A Phase IV, Multi-Center, Controlled, Open-label Study to Evaluate the Safety,Tolerability and Immunogenicity of Chiron Meningococcal C Conjugate VaccineMenjugate® when Given as First, Third or Fourth Immunization to Children 32 to 40Months of Age - N/A
Chiron Behring GmbH & Co. KG0 个研究点开始时间: 2005年3月1日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Children eligible to be enrolled in the study are those:
- •1. whose parents/legal guardians(s) have given written informed consent after the nature of the study has been explained
- •2. a. (Group E1 + E2) healthy children, who have either previously participated and completed study M14P1 and from whom at least serum samples from visit 5 and visit 6 or 7 could be evaluated, OR
- •2. b. (Group E3) healthy children aged 32 to 40 months who have never received any kind of meningococcal C vaccine before
- •3. available for the visits schedules in the study
- •4. in good health as determined by
- •- medical history
- •- clinical judgment of the investigator
- •- pre-vaccination physical check
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Children who are not eligible for the study are those:
- •1. Whose parent(s) / legal guardian(s) have not given or are unwilling to give written
- •informed consent to their child’s participation in the study
- •2. With known hypersensitivity to Menjugate, any of its components or any vaccines
- •contained within the routine immunization schedule
- •3. With unacceptable concurrent illnesses or conditions – i.e., children:
- •- with severe acute or chronic illness;
- •- who have any present or suspected serious disease such as metabolic, cardiac or
- •autoimmune disease or insulin dependent diabetes or any other serious disease
- •(e.g., with signs of cardiac or renal failure or severe malnutrition), including
- •progressive neurological disease
- •- with a genetic anomaly, e.g. Down’s syndrome
- •- with any immunodeficiency, including those requiring use of systemic
- •corticosteroids
- •- who have leukemia, lymphomas or neoplasm
- •- who have experienced significant acute or chronic infections requiring systemic
- •antibiotic treatment or antiviral therapy within the past 14 days
- •- who have experienced fever (defined as rectal temperature = 38.5°C) within the 3
- •days prior to study vaccination or are suffering from a present acute infectious
- •- who have a known bleeding diathesis, or any condition that may be associated
- •with a prolonged bleeding time
- •- who have a history of seizure disorder
- •- who have previously ascertained or suspected disease caused by N. meningitidis
- •- with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
- •4. With prohibited prior or concomitant medications:
- •- receipt of blood, blood products or a parenteral immunoglobulin preparation
- •- previous immunization with any non-study vaccines or investigational agents within 30 days prior to enrolment and throughout the study
- •- receipt of immunoglobulin
- •5. Who have household contact with or intimate exposure to an individual with a
- •positive culture of N. meningitidis serogroup C within the previous 60 days
- •6. Who previously received a meningococcal C vaccine of any kind (group E3 only)
- •7. Whose families are planning to leave the area of the study site permanently before the end of the study period
研究者
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