Preparedness for and Response to Meningococcal Outbreaks: a Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA
研究概览
简要总结
The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.
详细描述
A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 17 to 25 years.
- •Current or intended student at an educational setting in the 2015-2016 year.
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
排除标准
- •Significant renal or hepatic impairment.
- •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.
- •Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
- •Previous bacteriologically confirmed N. meningitidis disease.
- •Prior receipt of a meningococcal B vaccine
- •Hypersensitivity to any vaccine component of products used in this study (see product monographs)
- •Immunodeficiency or autoimmune disease
研究组 & 干预措施
Group 2: Standard Schedule
干预措施: Bexsero® (Biological)
Group 1: Accelerated Schedule
干预措施: Havrix® (Biological)
Group 1: Accelerated Schedule
干预措施: Bexsero® (Biological)
Group 2: Standard Schedule
干预措施: Havrix® (Biological)
结局指标
主要结局
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA
时间窗: Baseline to day 180
Immune responses will be measured: * Prior to 4CMenB vaccine (baseline) * To a single dose of 4CMenB vaccine 21 days post-immunization * 21 days after the second dose of an accelerated compared to a standard 4CMenB schedule * Six months after an accelerated 4CMenB vaccine schedule and a standard schedule
次要结局
- Number of solicited general adverse events(Day 0-6)
- Number of unsolicited general adverse events(Day 0-21)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 reported in the accelerated vaccine schedule compared to a standard schedule(From injection to Day 180)
- Number of solicited local and systemic injections site reactions(Day 0-6)
研究者
Joanne Langley
Principal Investigator
Canadian Immunization Research Network