EUCTR2008-006301-17-IT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 - ND
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点目标入组 3,600 人开始时间: 2009年1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
- 入组人数
- 3,600
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/ +29 days) 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
- •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 ≥ 38C 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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