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Hutterite Influenza Prevention Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00877396

First Posted: April 7, 2009

Last Update Posted: September 28, 2011

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.

Collaborator:

Canadian Institutes of Health Research (CIHR)

Information provided by (Responsible Party):

Mark Loeb, McMaster University

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: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines Hepatitis A Vaccines

U.S. FDA Resources

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

Information from the National Library of Medicine

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, 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

Information from the National Library of Medicine

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

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):

Wang B, Russell ML, Moss L, Fonseca K, Earn DJ, Aoki F, Horsman G, Caeseele PV, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD, Loeb M. Effect of Influenza Vaccination of Children on Infection Rate in Hutterite Communities: Follow-Up Study of a Randomized Trial. PLoS One. 2016 Dec 15;11(12):e0167281. doi: 10.1371/journal.pone.0167281. eCollection 2016.

Loeb M, Russell ML, Fonseca K, Webby R, Walter SD. Comparison of multiple estimates of efficacy for influenza vaccine. Vaccine. 2011 Dec 9;30(1):1-4. doi: 10.1016/j.vaccine.2011.10.069. Epub 2011 Nov 7.

Loeb M, Russell ML, Moss L, Fonseca K, Fox J, Earn DJ, Aoki F, Horsman G, Van Caeseele P, Chokani K, Vooght M, Babiuk L, Webby R, Walter SD. Effect of influenza vaccination of children on infection rates in Hutterite communities: a randomized trial. JAMA. 2010 Mar 10;303(10):943-50. doi: 10.1001/jama.2010.250.


Responsible Party:	Mark Loeb, Study Principal Investigator, McMaster University
ClinicalTrials.gov Identifier:	NCT00877396 History of Changes
Other Study ID Numbers:	MCT 88113
First Submitted:	January 22, 2009
First Posted:	April 7, 2009
Last Update Posted:	September 28, 2011
Last Verified:	September 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

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