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Hutterite Influenza Prevention Study

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ClinicalTrials.gov Identifier: NCT00877396
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : September 28, 2011
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mark Loeb, McMaster University

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date September 28, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
laboratory-confirmed influenza infection [ Time Frame: Dec to June each year for 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
  • Influenza like illness [ Time Frame: Dec to June each year for 3 years ]
  • Physician diagnosed otitis media [ Time Frame: Dec to June each year for 3 years ]
  • School or work related absenteeism [ Time Frame: Dec to June each year for 3 years ]
  • Physician visits for respiratory illness [ Time Frame: Dec to June each year for 3 years ]
  • Lower respiratory infection or pneumonia [ Time Frame: Dec to June each year for 3 years ]
  • Hospitalizations for LRTI or pneumonia [ Time Frame: Dec to June each year for 3 years ]
  • All cause hospitalizations [ Time Frame: Dec to June each year for 3 years ]
  • Deaths due to LRTI or pneumonia [ Time Frame: Dec to June each year for 3 years ]
  • All-cause deaths [ Time Frame: Dec to June each year for 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hutterite Influenza Prevention Study
Official Title  ICMJE Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Influenza vaccination
    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.
    Other Name: Vaxigrip by Sanofi Pasteur
  • Biological: Hepatitis A Vaccine
    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.
    Other Name: Avaxim Pediatric by Sanofi Pasteur
Study Arms  ICMJE
  • Experimental: Influenza
    Inactivated Influenza vaccination
    Intervention: Biological: Influenza vaccination
  • Placebo Comparator: Control
    Hepatitis A vaccine
    Intervention: Biological: Hepatitis A Vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2011)
4771
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
4500
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00877396
Other Study ID Numbers  ICMJE MCT 88113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Loeb, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Mark B Loeb, MD McMaster University
PRS Account McMaster University
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP