Hutterite Influenza Prevention Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00877396 |
Recruitment Status :
Completed
First Posted : April 7, 2009
Last Update Posted : September 28, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Influenza vaccination Biological: Hepatitis A Vaccine | Phase 4 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 4771 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- laboratory-confirmed influenza infection [ Time Frame: Dec to June each year for 3 years ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877396
Principal Investigator: | Mark B Loeb, MD | McMaster University |
Responsible Party: | Mark Loeb, Study Principal Investigator, McMaster University |
ClinicalTrials.gov Identifier: | NCT00877396 |
Other Study ID Numbers: |
MCT 88113 |
First Posted: | April 7, 2009 Key Record Dates |
Last Update Posted: | September 28, 2011 |
Last Verified: | September 2011 |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |