Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Hutterite Influenza Prevention Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mark Loeb, McMaster University
ClinicalTrials.gov Identifier:
NCT00877396
First received: January 22, 2009
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose
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.

Condition Intervention Phase
Influenza
 Biological: Influenza vaccination
Biological: Hepatitis A Vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • laboratory-confirmed influenza infection [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influenza like illness [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • Physician diagnosed otitis media [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • School or work related absenteeism [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • Physician visits for respiratory illness [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • Lower respiratory infection or pneumonia [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • Hospitalizations for LRTI or pneumonia [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • All cause hospitalizations [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • Deaths due to LRTI or pneumonia [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
  • All-cause deaths [ Time Frame: Dec to June each year for 3 years ] [ Designated as safety issue: No ]
Enrollment: 4771
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza
Inactivated Influenza vaccination
 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
Placebo Comparator: Control
Hepatitis A vaccine
 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

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.
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877396

Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mark B Loeb, MD McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mark Loeb, Study Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT00877396     History of Changes
Other Study ID Numbers: MCT 88113 
Study First Received: January 22, 2009
Last Updated: September 27, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
 Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016