Hutterite Influenza Prevention Study

NCT00877396 | Completed Phase 4 DMC

• 1 other identifier: MCT 88113
• Study Type: interventional
• Target: 4,771
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• laboratory-confirmed influenza infection

  Dec to June each year for 3 years

Secondary Outcomes (9)

• Influenza like illness

  Dec to June each year for 3 years

• Physician diagnosed otitis media

  Dec to June each year for 3 years

• School or work related absenteeism

  Dec to June each year for 3 years

• Physician visits for respiratory illness

  Dec to June each year for 3 years

• Lower respiratory infection or pneumonia

  Dec to June each year for 3 years

Study Arms (2)

Influenza

EXPERIMENTAL

Inactivated Influenza vaccination

Biological: Influenza vaccination

Control

PLACEBO COMPARATOR

Hepatitis A vaccine

Biological: Hepatitis A Vaccine

Interventions

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.

Also known as: Vaxigrip by Sanofi Pasteur

Influenza

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.

Also known as: Avaxim Pediatric by Sanofi Pasteur

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Group B:
• Healthy children aged 36 months to 15 years who will be immunized as part of the intervention.
• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (3)

• 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.

  PMID: 27977707 DERIVED

• 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.

  PMID: 22098676 DERIVED

• 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.

  PMID: 20215608 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines

Study Officials

• Mark B Loeb, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: April 7, 2009
• Study Start: September 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 28, 2011

Record last verified: 2011-09