Live Versus Inactivated Influenza Vaccine Study in Hutterite Children
A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
1 other identifier
interventional
4,611
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 26, 2018
October 1, 2018
2.6 years
July 26, 2012
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Laboratory-confirmed influenza infection.
up to 3 years
Secondary Outcomes (10)
Influenza like illness.
December to June each year for 3 years.
Physician diagnosed otitis media.
December to June each year for 3 years.
Antimicrobial prescriptions.
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.
- +5 more secondary outcomes
Study Arms (2)
Influenza vaccine LAIV
EXPERIMENTALLive attenuated influenza vaccine (LAIV).
Influenza vaccine TIV
ACTIVE COMPARATORTrivalent inactivated vaccine (TIV).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.
You may not qualify if:
- anaphylactic reaction to a previous dose of LAIV or TIV
- known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
- history of asthma
- medically diagnosed or treated wheezing within 42 days before enrollment
- Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
- anaphylactic reaction to gentamicin
- anaphylactic reaction to gelatin
- anaphylactic reaction to neomycin
- anaphylactic reaction to arginine
- pregnancy
- household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
- use of aspirin or salicylate-containing products within 30 days before enrollment.
- Group B:
- other Hutterite community members that are not in Group A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
McMaster University
Hamilton, Ontario, L8S 4K1, Canada
Related Publications (1)
Loeb M, Russell ML, Manning V, Fonseca K, Earn DJ, Horsman G, Chokani K, Vooght M, Babiuk L, Schwartz L, Neupane B, Singh P, Walter SD, Pullenayegum E. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. 2016 Nov 1;165(9):617-624. doi: 10.7326/M16-0513. Epub 2016 Aug 16.
PMID: 27538259DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark B Loeb, MD, MSc
McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
October 26, 2018
Record last verified: 2018-10