Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Fluad; Biological: Fluzone

• Registration Number: NCT02871206
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2016-11
• Primary Completion: 2019-06
• Study Completion: 2019-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3425

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvanted Influenza Vaccine	Fluad	Fluad. A 0.25 ml intramuscular dose of the vaccine will be administered to children aged from 6 months to less than 36 months and a 0.5ml dose will be administered to children aged from 36 months to 6 years. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.25 ml dose of the vaccine four weeks following the first vaccine as per influenza immunization recommendations if they are aged between 6 months and less than 36 months or a second dose of 0.5ml if they are aged from 36 months to 6 years.
Quadrivalent Influenza Vaccine	Fluzone	Fluzone. A 0.5 ml dose of the vaccine will be 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 of the influenza vaccine four weeks following the first vaccine as per influenza immunization recommendations.

Primary Outcome Measures

Name	Time	Method
Laboratory-confirmed influenza infection	Up to 3 years

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada