A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,425
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed influenza infection
研究概览
简要总结
This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6 months to 72 months
排除标准
- •Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components
- •Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- •Guillain- Barré syndrome within eight weeks of a previous influenza vaccine
- •Use of aspirin or salicylate- containing products within 30 days before enrollment
- •Inclusion Criteria:
- •household and extended family members of children in Group A
- •extended family is defined as the household members of the grandparents of the children in Group A
- •Exclusion Criteria:
- •there are no exclusion criteria for this category of participants
- •Inclusion Criteria:
- •other Hutterite community members that are not in Group A
- •Exclusion Criteria:
- •there are no exclusion criteria for this category of participants
研究组 & 干预措施
Adjuvanted Influenza Vaccine
Fluad. A 0.25 ml intramuscular dose of the vaccine will be administered to children aged from 6 months to less than 36 months and a 0.5ml dose will be administered to children aged from 36 months to 6 years. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.25 ml dose of the vaccine four weeks following the first vaccine as per influenza immunization recommendations if they are aged between 6 months and less than 36 months or a second dose of 0.5ml if they are aged from 36 months to 6 years.
干预措施: Fluad (Biological)
Quadrivalent Influenza Vaccine
Fluzone. A 0.5 ml dose of the vaccine will be administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose of the influenza vaccine four weeks following the first vaccine as per influenza immunization recommendations.
干预措施: Fluzone (Biological)
结局指标
主要结局
Laboratory-confirmed influenza infection
时间窗: Up to 3 years
次要结局
未报告次要终点