Hutterite Influenza Prevention Study
Information source: McMaster University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Influenza vaccination (Biological); Hepatitis A Vaccine (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: McMaster University Official(s) and/or principal investigator(s): Mark B Loeb, MD, Principal Investigator, Affiliation: McMaster University
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.
Clinical Details
Official title: Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: laboratory-confirmed influenza infection
Secondary outcome: Influenza like illnessPhysician 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
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: September 2008
Last updated: September 27, 2011
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