Influenza
Conditions
Brief summary
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.
Interventions
BIOLOGICALFluad
BIOLOGICALFluzone
Sponsors
University of Calgary
University of Saskatchewan
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Group A: Receive Intervention Inclusion Criteria: -Healthy children aged 6 months to 72 months
Exclusion criteria
* 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 Group B: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory-confirmed influenza infection | Up to 3 years |
Countries
Canada
Outcome results
None listed