EUCTR2008-006301-17-FI进行中（未招募）不适用
A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13
ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2009年2月27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
- •Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. Subjects eligible to be enrolled in the study should comply with the following criteria: 1. healthy 12-month-old toddlers (0/ +59days) who completed Study V72P13; 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. Previous ascertained or suspected disease caused by N. meningitidis; 2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 3. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4. Significant acute or chronic infection within the previous 7 days or axillary temperature = 38°C within the previous day; 5. Antibiotics within 6 days prior to enrollment; 6. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 7. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth; 8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 9. Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
- •10. Participation in a clinical trial other than Study V72P13 since birth or planned for during this extension study; 11. Family members and household members of research staff; 12. 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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