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NCT Number: NCT00877396

Hutterite Influenza Prevention Study

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza vaccination

Biological

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 names: Vaxigrip by Sanofi Pasteur

Hepatitis A Vaccine

Biological

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 names: Avaxim Pediatric by Sanofi Pasteur

Primary outcomes

  1. laboratory-confirmed influenza infection

    Time frame: Dec to June each year for 3 years

Secondary outcomes

  1. Influenza like illness

    Time frame: Dec to June each year for 3 years

  2. Physician diagnosed otitis media

    Time frame: Dec to June each year for 3 years

  3. School or work related absenteeism

    Time frame: Dec to June each year for 3 years

  4. Physician visits for respiratory illness

    Time frame: Dec to June each year for 3 years

  5. Lower respiratory infection or pneumonia

    Time frame: Dec to June each year for 3 years

  6. Hospitalizations for LRTI or pneumonia

    Time frame: Dec to June each year for 3 years

  7. All cause hospitalizations

    Time frame: Dec to June each year for 3 years

  8. Deaths due to LRTI or pneumonia

    Time frame: Dec to June each year for 3 years

  9. All-cause deaths

    Time frame: Dec to June each year for 3 years

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2009
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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