EUCTR2011-004931-30-ES进行中（未招募）不适用
A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fift Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1 - Not applicable
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 1,560 人开始时间: 2012年7月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,560
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. A) Inclusion Criteria for naive subjects, newly enrolled (Group 7): 1. 4 years old (48 months ± 180 days window) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. 2. for whom a parent/legal guardian(s) has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian(s) confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. B) Inclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Inclusion criteria are the same as for Groups 7, with the addition that they are subjects who completed the vaccination course of V72P12E1 study, who are 4 years old and above (preferably closer to 4 years of age).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1560
- •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
- •A)Exclusion Criteria for naïve subjects, newly enrolled (Group 7):1. subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study;2.history of any meningococcal B vaccine administration;
- •3.previous ascertained or suspected disease caused by N.meningitidis;4.household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;5.history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •6.significant acute or chronic infection within the previous 7 days or axillary
- •temperature >=38°C within the day before Visit 1;7. systemic use of antibiotics for treatment of significant acute or chronic infections within 7 days prior to Visit 1;
- •8.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);9. known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of
- •inhaled high-potency corticosteroids within 30 days prior to Visit 1;10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11. receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to Visit 1 (with the exception of licensed flu vaccine, which can be administered at any time during the study period, but not within 14 days of vaccination with rMenB+OMV NZ);12. participation in another clinical trial (except V72P12E1) within 90 days prior to
- •enrolment or planned for during study;
- •13. family members and household members of research staff. 14. any condition which, in the opinion of the investigator, might interfere with the
- •evaluation of the study objectives.
- •B. Exclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6):
- •Exclusion criteria are the same as for Group 7, with the exception of criterion 2.
研究者
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