EUCTR2004-000195-13-GB进行中（未招募）1 期
A Phase II, Randomized, Open label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory after Two or Three Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
ovartis Vaccines and Diagnostics0 个研究点目标入组 601 人开始时间: 2005年2月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 601
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
入选标准
- •1.healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg;
- •2.for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
- •3.available for all 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:
- •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. who previously received any meningococcal vaccine;
- •2.who received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, HBV, H. influenzae type b (Hib) or Pneumococcus;
- •3. who have a previous ascertained or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping);
- •4. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- •5. who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (³38.0°C) within the previous 3 days;
- •6. who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome);
- •7. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):a)receipt of any immunosuppressive therapy since birthb)receipt of immunostimulants since birthc)receipt of any sytemic corticosteroid since birth
- •8. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
- •9. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •10. who have taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who have received an oral or parenteral ß-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose);
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