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Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Trivalent Inactivated Vaccine

Live Attenuated Influenza Vaccine

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Group A:

Inclusion criteria:

healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion criteria:

anaphylactic reaction to a previous dose of LAIV or TIV
known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
history of asthma
medically diagnosed or treated wheezing within 42 days before enrollment
Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
anaphylactic reaction to gentamicin
anaphylactic reaction to gelatin
anaphylactic reaction to neomycin
anaphylactic reaction to arginine
pregnancy
household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

Inclusion Criteria

other Hutterite community members that are not in Group A

Exclusion Criteria:

there are no exclusion criteria for this category of participants

Sites / Locations

McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Influenza vaccine LAIV

Influenza vaccine TIV

Arm Description

Live attenuated influenza vaccine (LAIV).

Trivalent inactivated vaccine (TIV).

Outcomes

Primary Outcome Measures

Laboratory-confirmed influenza infection.

Secondary Outcome Measures

Influenza like illness.

Physician diagnosed otitis media.

Antimicrobial prescriptions.

School or work related absenteeism.

Physician visits for respiratory illness.

Lower respiratory infection or pneumonia.

Hospitalization for lower respiratory infection or pneumonia.

All cause hospitalizations.

Deaths due to lower respiratory infections or pneumonia.

All cause deaths.

Full Information

NCT ID

NCT01653015

First Posted

July 26, 2012

Last Updated

October 25, 2018

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT01653015

Brief Title

Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

Official Title

A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

November 2012 (Actual)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

Detailed Description

The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Influenza vaccine LAIV

Arm Type

Experimental

Arm Description

Live attenuated influenza vaccine (LAIV).

Arm Title

Influenza vaccine TIV

Arm Type

Active Comparator

Arm Description

Trivalent inactivated vaccine (TIV).

Intervention Type

Biological

Intervention Name(s)

Trivalent Inactivated Vaccine

Other Intervention Name(s)

VAXIGRIP by Sanofi Pasteur

Intervention Description

Influenza vaccination, 0.5 ml dose 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 four weeks later.

Intervention Type

Biological

Intervention Name(s)

Live Attenuated Influenza Vaccine

Other Intervention Name(s)

FLUMIST by Mediummune.

Intervention Description

Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.

Primary Outcome Measure Information:

Title

Laboratory-confirmed influenza infection.

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

Influenza like illness.

Time Frame