A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 3
- 主要终点
- Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the following need to be fulfilled:
- •Healthy adolescent
- •Previous receipt of appropriate MenC vaccine according to the relevant provincial schedule (see above)
- •Parent/legal guardian has given informed consent OR participant has given consent (if participant demonstrates capacity to consent)
- •Participant has given consent (as above) OR assent.
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •Has already received any doses of MenACWY vaccine at any age
- •Previous confirmed or suspected meningococcal disease
- •Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months
- •Previous allergic reaction to a component of any of the 3 vaccines
- •Serious chronic or progressive disease
- •Confirmed/suspected immunodeficiency
- •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
- •Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period
- •Pregnancy (based on history from adolescent and parent/legal guardian)
- •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.
研究组 & 干预措施
Group 1A
3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
干预措施: MenACWY-CRM (Biological)
Group 1B
3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
干预措施: MenACWY-DT (Biological)
Group 2B
2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
干预措施: MenACWY-DT (Biological)
Group 3B
1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
干预措施: MenACWY-DT (Biological)
Group 2C
2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
干预措施: MenACWY-TT (Biological)
Group 3C
1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
干预措施: MenACWY-TT (Biological)
Group 3A
1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
干预措施: MenACWY-CRM (Biological)
Group 2A
2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
干预措施: MenACWY-CRM (Biological)
Group 1C
3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
干预措施: MenACWY-TT (Biological)
结局指标
主要结局
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules
时间窗: 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
时间窗: 1 year following MenACWY adolescent booster
N. meningitidis capsular group C serum bactericidal antibody titer
次要结局
- Subgroup analysis to determine effects of different MenACWY vaccines in subjects primed with different MenC schedules at 1 month and 1 year post-MenACWY booster(1 month and 1 year following MenACWY booster)
- Confirm safety of MenACWY conjugate vaccines(Up to 1 month post-vaccine)
- Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules.(1 month following MenACWY booster)
- Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines(1 month following MenACWY booster)
- Subgroup analysis to determine effects of different MenC priming schedules in subjects receiving different MenACWY booster immunizations at 1 month and 1 year post-MenACWY booster(1 month and 1 year following MenACWY booster)