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Hutterite Influenza Prevention Study
This study has been completed.
Sponsor:
McMaster University
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
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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 (Participant, 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:
Further study details as provided by Mark Loeb, McMaster University:
Primary Outcome Measures:
- laboratory-confirmed influenza infection [ Time Frame: Dec to June each year for 3 years ]
Secondary Outcome Measures:
- 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 ]
| 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 |
| Sexes Eligible for Study: | All |
| 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
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 |
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 July 21, 2017