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Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

2018年10月25日 更新者：McMaster University

A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

4611

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Hamilton、Ontario、加拿大、L8S 4K1
        • McMaster University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Group A:

Inclusion criteria:

  • healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion criteria:

  1. anaphylactic reaction to a previous dose of LAIV or TIV
  2. known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
  3. history of asthma
  4. medically diagnosed or treated wheezing within 42 days before enrollment
  5. Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
  6. anaphylactic reaction to gentamicin
  7. anaphylactic reaction to gelatin
  8. anaphylactic reaction to neomycin
  9. anaphylactic reaction to arginine
  10. pregnancy
  11. household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
  12. use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

Inclusion Criteria

  • other Hutterite community members that are not in Group A

Exclusion Criteria:

  • there are no exclusion criteria for this category of participants

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Influenza vaccine LAIV
Live attenuated influenza vaccine (LAIV).
生物：Trivalent Inactivated Vaccine
Influenza vaccination, 0.5 ml dose 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 four weeks later.
其他名称：
  • VAXIGRIP by Sanofi Pasteur
有源比较器：Influenza vaccine TIV
Trivalent inactivated vaccine (TIV).
生物：Live Attenuated Influenza Vaccine
Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.
其他名称：
  • FLUMIST by Mediummune.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Laboratory-confirmed influenza infection.
大体时间：up to 3 years
up to 3 years

次要结果测量

结果测量
大体时间
Influenza like illness.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Physician diagnosed otitis media.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Antimicrobial prescriptions.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
School or work related absenteeism.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Physician visits for respiratory illness.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Lower respiratory infection or pneumonia.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Hospitalization for lower respiratory infection or pneumonia.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
All cause hospitalizations.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
Deaths due to lower respiratory infections or pneumonia.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.
All cause deaths.
大体时间：December to June each year for 3 years.
December to June each year for 3 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

McMaster University

合作者

Canadian Institutes of Health Research (CIHR)

调查人员

  • 首席研究员：Mark B Loeb, MD, MSc、McMaster University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年11月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2012年7月26日

首先提交符合 QC 标准的

2012年7月27日

首次发布 (估计)

2012年7月30日

研究记录更新

最后更新发布 (实际的)

2018年10月26日

上次提交的符合 QC 标准的更新

2018年10月25日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • RC1-274129

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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