Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

McMaster University

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Fluad; Biological: Fluzone

Study type: Interventional

Funder types: Other

Identifiers

NCT02871206

AV-IIV

Details and patient eligibility

About

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.

Enrollment: 3,425 patients

Sex: All

Ages: 6 to 72 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,425 participants in 2 patient groups

Adjuvanted Influenza Vaccine

Experimental group

Description:

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.

Treatment:

Biological: Fluad

Quadrivalent Influenza Vaccine

Active Comparator group

Description:

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.

Treatment:

Biological: Fluzone