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Hutterite Influenza Prevention Study

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Influenza vaccination
Hepatitis A Vaccine
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Hutterites other than the healthy children who will be immunized. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups:
  • individuals aged ≥ 65 years
  • children 23 months of age or less

  • anyone with ≥ 1 of the following conditions severe enough to require regular medical follow-up or hospital care:

    • chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma)
    • diabetes mellitus and other metabolic diseases
    • cancer
    • immunodeficiency
    • immunosuppression (due to underlying disease and/or therapy)
    • renal disease
    • anemia
    • hemoglobinopathy
    • any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration.

Exclusion Criteria:

  • There are no exclusion criteria for this category of participants.

Group B:

Inclusion Criteria:

  • Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion Criteria:

  • Anaphylactic reaction to a previous dose of influenza vaccine
  • Anaphylactic reaction to hepatitis A vaccine
  • Anaphylactic reaction to neomycin
  • Known 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Influenza

    Control

    Arm Description

    Inactivated Influenza vaccination

    Hepatitis A vaccine

    Outcomes

    Primary Outcome Measures

    laboratory-confirmed influenza infection

    Secondary Outcome Measures

    Influenza like illness
    Physician diagnosed otitis media
    School or work related absenteeism
    Physician visits for respiratory illness
    Lower respiratory infection or pneumonia
    Hospitalizations for LRTI or pneumonia
    All cause hospitalizations
    Deaths due to LRTI or pneumonia
    All-cause deaths

    Full Information

    First Posted
    January 22, 2009
    Last Updated
    September 27, 2011
    Sponsor
    McMaster University
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00877396
    Brief Title
    Hutterite Influenza Prevention Study
    Official Title
    Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.
    Detailed Description
    Colonies will be enrolled in September 2008. Healthy Hutterite Children will be vaccinated in October, in each year of the study (2008, 2009, & 2010) Influenza Surveillance phase will begin around December-January of each year. All study outcomes will be collected during the Surveillance phase of the study from Dec to June for 3 years. Outcomes will be collected when research nurses visit the colonies. A research nurse will visit enrolled colonies twice a week during the surveillance phase and review study diaries and obtain swabs from participants with symptoms of influenza.

    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
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    4771 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Influenza
    Arm Type
    Experimental
    Arm Description
    Inactivated Influenza vaccination
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Hepatitis A vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    Influenza vaccination
    Other Intervention Name(s)
    Vaxigrip by Sanofi Pasteur
    Intervention Description
    Influenza vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose (0.5 mL) 4 weeks later.
    Intervention Type
    Biological
    Intervention Name(s)
    Hepatitis A Vaccine
    Other Intervention Name(s)
    Avaxim Pediatric by Sanofi Pasteur
    Intervention Description
    Hepatitis vaccination- 0.5 mL. Children under 9 who have never received a influenza vaccine will receive a 2nd dose ( saline- 0.5 mL) 4 weeks later.
    Primary Outcome Measure Information:
    Title
    laboratory-confirmed influenza infection
    Time Frame
    Dec to June each year for 3 years
    Secondary Outcome Measure Information:
    Title
    Influenza like illness
    Time Frame
    Dec to June each year for 3 years
    Title
    Physician diagnosed otitis media
    Time Frame
    Dec to June each year for 3 years
    Title
    School or work related absenteeism
    Time Frame
    Dec to June each year for 3 years
    Title
    Physician visits for respiratory illness
    Time Frame
    Dec to June each year for 3 years
    Title
    Lower respiratory infection or pneumonia
    Time Frame
    Dec to June each year for 3 years
    Title
    Hospitalizations for LRTI or pneumonia
    Time Frame
    Dec to June each year for 3 years
    Title
    All cause hospitalizations
    Time Frame
    Dec to June each year for 3 years
    Title
    Deaths due to LRTI or pneumonia
    Time Frame
    Dec to June each year for 3 years
    Title
    All-cause deaths
    Time Frame
    Dec to June each year for 3 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Group A: Inclusion Criteria: Hutterites other than the healthy children who will be immunized. Although this category as a whole will be used to assess indirect benefit of the vaccine in the main analysis, Hutterites at high risk for influenza complications within this category will be assessed in a separate analysis. These are defined as anyone in one or more of the following groups: individuals aged ≥ 65 years children 23 months of age or less anyone with ≥ 1 of the following conditions severe enough to require regular medical follow-up or hospital care: chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma) diabetes mellitus and other metabolic diseases cancer immunodeficiency immunosuppression (due to underlying disease and/or therapy) renal disease anemia hemoglobinopathy any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration. Exclusion Criteria: There are no exclusion criteria for this category of participants. Group B: Inclusion Criteria: Healthy children aged 36 months to 15 years who will be immunized as part of the intervention. Exclusion Criteria: Anaphylactic reaction to a previous dose of influenza vaccine Anaphylactic reaction to hepatitis A vaccine Anaphylactic reaction to neomycin Known 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark B Loeb, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27977707
    Citation
    Wang B, Russell ML, Moss L, Fonseca K, Earn DJ, Aoki F, Horsman G, Caeseele PV, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD, Loeb M. Effect of Influenza Vaccination of Children on Infection Rate in Hutterite Communities: Follow-Up Study of a Randomized Trial. PLoS One. 2016 Dec 15;11(12):e0167281. doi: 10.1371/journal.pone.0167281. eCollection 2016.
    Results Reference
    derived
    PubMed Identifier
    22098676
    Citation
    Loeb M, Russell ML, Fonseca K, Webby R, Walter SD. Comparison of multiple estimates of efficacy for influenza vaccine. Vaccine. 2011 Dec 9;30(1):1-4. doi: 10.1016/j.vaccine.2011.10.069. Epub 2011 Nov 7.
    Results Reference
    derived
    PubMed Identifier
    20215608
    Citation
    Loeb M, Russell ML, Moss L, Fonseca K, Fox J, Earn DJ, Aoki F, Horsman G, Van Caeseele P, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD. Effect of influenza vaccination of children on infection rates in Hutterite communities: a randomized trial. JAMA. 2010 Mar 10;303(10):943-50. doi: 10.1001/jama.2010.250.
    Results Reference
    derived

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    Hutterite Influenza Prevention Study

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