NCT02871206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,425

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

August 15, 2016

Last Update Submit

November 19, 2024

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Laboratory-confirmed influenza infection

    Up to 3 years

Study Arms (2)

Adjuvanted Influenza Vaccine

EXPERIMENTAL

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.

Biological: Fluad

Quadrivalent Influenza Vaccine

ACTIVE COMPARATOR

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.

Biological: Fluzone

Interventions

FluadBIOLOGICAL
Adjuvanted Influenza Vaccine
FluzoneBIOLOGICAL
Quadrivalent Influenza Vaccine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy children aged 6 months to 72 months

You may not qualify if:

  • 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:
  • 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
  • Group C:
  • other Hutterite community members that are not in Group A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Switzer C, Verschoor CP, Pullenayegum E, Singh P, Loeb M. Adjuvant-attenuated symptom severity of influenza infections in vaccinated children. Infect Med (Beijing). 2022 Sep 15;1(3):163-170. doi: 10.1016/j.imj.2022.09.002. eCollection 2022 Sep.

    PMID: 38077624DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

fluad vaccineInfluenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Mark Loeb, MD, MSc.

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

CA(1)