Hutterite Influenza Prevention Study

NCT ID: NCT00877396

Last Updated: 2011-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4771 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Influenza

Inactivated Influenza vaccination

Group Type: EXPERIMENTAL

Influenza vaccination

Intervention Type: 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.

Control

Hepatitis A vaccine

Group Type: PLACEBO_COMPARATOR

Hepatitis A Vaccine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Vaxigrip by Sanofi Pasteur; Avaxim Pediatric by Sanofi Pasteur

Eligibility Criteria

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.

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

Exclusion Criteria

Group B:

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Mark Loeb

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark B Loeb, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

References

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.

Reference Type: DERIVED

PMID: 27977707 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22098676 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20215608 (View on PubMed)

Other Identifiers

MCT 88113

Identifier Type: -

Identifier Source: org_study_id