A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4,611
- 试验地点
- 2
- 主要终点
- Laboratory-confirmed influenza infection.
研究概览
简要总结
There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.
详细描述
The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •there are no exclusion criteria for this category of participants
研究组 & 干预措施
Influenza vaccine TIV
Trivalent inactivated vaccine (TIV).
干预措施: Live Attenuated Influenza Vaccine (Biological)
Influenza vaccine LAIV
Live attenuated influenza vaccine (LAIV).
干预措施: Trivalent Inactivated Vaccine (Biological)
结局指标
主要结局
Laboratory-confirmed influenza infection.
时间窗: up to 3 years
次要结局
- Influenza like illness.(December to June each year for 3 years.)
- All cause deaths.(December to June each year for 3 years.)
- Physician diagnosed otitis media.(December to June each year for 3 years.)
- All cause hospitalizations.(December to June each year for 3 years.)
- Antimicrobial prescriptions.(December to June each year for 3 years.)
- Lower respiratory infection or pneumonia.(December to June each year for 3 years.)
- Hospitalization for lower respiratory infection or pneumonia.(December to June each year for 3 years.)
- School or work related absenteeism.(December to June each year for 3 years.)
- Physician visits for respiratory illness.(December to June each year for 3 years.)
- Deaths due to lower respiratory infections or pneumonia.(December to June each year for 3 years.)