EUCTR2006-005589-38-GB进行中（未招募）1 期
A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 60 人开始时间: 2007年1月7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
- 60
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 6-8 months old infants;
- •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
- •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. whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study;
- •2. who have previously received any meningococcal B vaccine;
- •3. who have a previous ascertained or suspected disease caused by N. meningitidis;
- •4. who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
- •5. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- •6. who have experienced fever (defined as axillary temperature =38.0°C) within the previous 3 days or are suffering from a present acute infection disease;
- •7. who have any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome);
- •8. who have leukemia, lymphomas;
- •9. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
- •a. receipt of any immunosuppressive therapy
- •b. receipt of any systemic corticosteroid or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression (e.g., 1 mg/kg/day of prednisone [or its equivalent])
- •c. chronic use of inhaled high-potency corticosteroids (e.g., budesonide 800 µg per day or fluticasone 750 µg per day);
- •10. with a suspected or known HIV infection or HIV related disease;
- •11. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study;
- •12. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •13. who have experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome;
- •14. who have received antibiotics within 6 days prior to enrollment;
- •15. who have either received, or for whom there is intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period [Exception: the applicable routine immunization (e.g. MMR, MCC-Hib, PC7) are allowed];
- •16. have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study;
- •17. whose parents/legal guardians, are planning to leave the area of the study site before the end of the study period;
- •18. with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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