EUCTR2005-000924-18-DE进行中（未招募）不适用
A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age;
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 260 人开始时间: 2005年4月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •Healthy infants (7 to 11 weeks of age), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg;
- •for whom the parents/legal guardians have given written informed consent after the nature of the study has been explained;
- •who are available for all the visits scheduled in the study;
- •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
- •Whose parents/legal guardians are unwilling or unable to give written informed consent to their child’s participation in the study;
- •Who previously received Meningococcal C vaccine of any kind;
- •Who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, history of microbiologically proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping;
- •Who have had household contact with and/or intimate exposure to an individual with microbiologically proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days;
- •Who have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 60 days prior to enrolment, through to 30 days following any study vaccine administration; except for the vaccination against Tuberculosis which is allowed to be given to the subjects in the Polish sites since this is a legally required infant vaccination in Poland given to the child at birth and except for the Hepatitis B vaccination given in Poland at birth as well and except for vaccination with DTaP-IPV-HBV/Hib, which as routine infant vaccination is allowed to be given concomitantly to the study medication as indicated in the time and events table above.
- •Who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •Who received prior vaccination with DTaP-IPV-HBV/Hib or any of the components (before the age of 2 months), unless the exception for Hepatitis B in Poland applies;
- •Who have experienced fever (rectal temperature = 38.5°C) within the past 3 days or are suffering from a present acute infectious disease;
- •Who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 10 days;
- •Who have any present or suspected serious chronic disease such as cardiac or autoimmune disease or insulin dependent diabetes;
- •Who have leukemia, lymphomas, neoplasm;
- •With a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including use of corticosteroids known to be associated with suppression of hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids [eg 1 mg/kg/day of prednisone or its equivalent] or chronic use of inhaled high-potency corticosteroids [budesonide 800 µg per day or fluticasone 750 µg per day]). Those subjects who are known to have asthma and did conclude a systemic corticosteroid therapy above the mentioned limit at least 30 days previous to entering the study shall not be excluded.
- •Who have received blood, blood products or a parenteral immunoglobulin preparation;
- •With a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •Who have any other serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
- •Who have a history of seizure disorder;
- •With an genetic anomaly (known cytogenic disorders) e.g., Down’s syndrome;
- •Who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period;
- •With any condition which, in t
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