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Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02871206
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : January 10, 2017
University of Calgary
University of Saskatchewan
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluad Biological: Fluzone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Adjuvanted Influenza Vaccine
Biological: Fluad
Active Comparator: Quadrivalent Influenza Vaccine
Biological: Fluzone

Primary Outcome Measures :
  1. Laboratory-confirmed influenza infection [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 members of children in Group A

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02871206

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Contact: Mark Loeb, MD, MSc. 905-525-9140 ext 26066

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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Mark B Loeb, MD, MSc    905-525-9140 ext 26066   
Principal Investigator: Mark B Loeb, MD, MSc         
Sponsors and Collaborators
McMaster University
University of Calgary
University of Saskatchewan
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Principal Investigator: Mark Loeb, MD, MSc. McMaster University

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Responsible Party: McMaster University Identifier: NCT02871206     History of Changes
Other Study ID Numbers: AV-IIV
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs