Adolescent MenACWY Booster Study
赞助:
Canadian Immunization Research Network
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | September 20, 2018 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules[ Time Frame: 1 year following MenACWY adolescent booster ] N. meningitidis capsular group C serum bactericidal antibody titer Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines[ Time Frame: 1 year following MenACWY adolescent booster ] N. meningitidis capsular group C serum bactericidal antibody titer |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Adolescent MenACWY Booster Study | ||
| 正式标题 ICMJE | A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study. | ||
| 简要概况 | This study is to confirm non-inferiority of the three MenACWY vaccines (Menveo, Menactra or Nimenrix) in adolescents, and to identify whether the number of previous doses of MenC influences the response to the MenACWY vaccine. |
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| 详细说明 | Participants will be randomized to receive one of the three doses of licensed MenACWY as a booster dose in adolescents. Serology will be collect at 3 time points; prior to the booster dose and 1 month and 1 year post-vaccination to measure antibody levels. The participants are healthy students in grades 7-9 who have not received their MenACWY vaccine yet and received their routine infant MenC vaccines per previous Canadian schedules. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Group 1 = 3 prior doses of MenC vaccine (Alberta), Group 2 = 2 prior doses of MenC vaccine (British Columbia), Group 3 = 1 prior dose of MenC vaccine (Nova Scotia). Group A = Menveo (MenACWY-CRM), Group B = Menactra (MenACWY-DT), Group C = Nimenrix (MenACWY-TT) 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
324 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 2020 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | INCLUSION CRITERIA All the following need to be fulfilled: 1. Healthy adolescent 2. Previous receipt of appropriate MenC vaccine according to the relevant provincial schedule (see above) 3. Parent/legal guardian has given informed consent OR participant has given consent (if participant demonstrates capacity to consent) 4. Participant has given consent (as above) OR assent. EXCLUSION CRITERIA The participant may not enter the trial if ANY of the following apply: 1. Has already received any doses of MenACWY vaccine at any age 2. Previous confirmed or suspected meningococcal disease 3. Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months 4. Previous allergic reaction to a component of any of the 3 vaccines 5. Serious chronic or progressive disease 6. Confirmed/suspected immunodeficiency 7. Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed 8. Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period 9. Pregnancy (based on history from adolescent and parent/legal guardian) 10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. TEMPORARY EXCLUSION CRITERIA If the adolescent has a temperature ≥ 38°C, then vaccination (and blood sampling if due to occur at same visit) will be postponed until resolution of fever. | ||
| 性别 |
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| 年龄 | 最小年龄：11 Years ，最大年龄：15 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Canada | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Canadian Immunization Research Network | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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