Hutterite Influenza Prevention Study

Influenza Clinical Trial

Official title:

Does Vaccinating Health Hutterite Children Against Influenza Prevent Influenza in Other Hutterite Colony Members: A Randomized Cluster Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877396
• Other study ID #: MCT 88113
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2009
• Last updated: September 27, 2011
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4771
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laboratory-confirmed influenza infection		Dec to June each year for 3 years	No
Secondary	Influenza like illness		Dec to June each year for 3 years	No
Secondary	Physician diagnosed otitis media		Dec to June each year for 3 years	No
Secondary	School or work related absenteeism		Dec to June each year for 3 years	No
Secondary	Physician visits for respiratory illness		Dec to June each year for 3 years	No
Secondary	Lower respiratory infection or pneumonia		Dec to June each year for 3 years	No
Secondary	Hospitalizations for LRTI or pneumonia		Dec to June each year for 3 years	No
Secondary	All cause hospitalizations		Dec to June each year for 3 years	No
Secondary	Deaths due to LRTI or pneumonia		Dec to June each year for 3 years	No
Secondary	All-cause deaths		Dec to June each year for 3 years	No