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NCT Number: NCT02871206

Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • there are no exclusion criteria for this category of participants

Group C:

Inclusion criteria

  • other Hutterite community members that are not in Group A

Exclusion criteria

  • there are no exclusion criteria for this category of participants

Treatment and study plan

Fluad

Biological

Fluzone

Biological

Primary outcomes

  1. Laboratory-confirmed influenza infection

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • University of Calgary
  • University of Saskatchewan

Registry information

Official study title

A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2016
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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