Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

NCT ID: NCT02871206

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-07-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Adjuvanted Influenza Vaccine

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.

Group Type: EXPERIMENTAL

Fluad

Intervention Type: BIOLOGICAL

Quadrivalent Influenza Vaccine

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.

Group Type: ACTIVE_COMPARATOR

Fluzone

Intervention Type: BIOLOGICAL

Interventions

Fluad

Intervention Type: BIOLOGICAL

Fluzone

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

-Healthy children aged 6 months to 72 months

• 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

• other Hutterite community members that are not in Group A

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:

Group C:

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Loeb, MD, MSc.

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38077624 (View on PubMed)

Other Identifiers

AV-IIV

Identifier Type: -

Identifier Source: org_study_id