Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

NCT ID: NCT01653015

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-12-31

Brief Summary

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

Detailed Description

The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.

Conditions

Influenza

Study Design

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

Study Groups

Influenza vaccine LAIV

Live attenuated influenza vaccine (LAIV).

Group Type: EXPERIMENTAL

Trivalent Inactivated Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccination, 0.5 ml dose administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose four weeks later.

Influenza vaccine TIV

Trivalent inactivated vaccine (TIV).

Group Type: ACTIVE_COMPARATOR

Live Attenuated Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.

Interventions

Trivalent Inactivated Vaccine

Influenza vaccination, 0.5 ml dose administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose four weeks later.

Intervention Type: BIOLOGICAL

Live Attenuated Influenza Vaccine

Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.

Intervention Type: BIOLOGICAL

Other Intervention Names

VAXIGRIP by Sanofi Pasteur; FLUMIST by Mediummune.

Eligibility Criteria

Inclusion Criteria

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

• other Hutterite community members that are not in Group A

Exclusion Criteria

1. anaphylactic reaction to a previous dose of LAIV or TIV

2. known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock

3. history of asthma

4. medically diagnosed or treated wheezing within 42 days before enrollment

5. Guillain-Barré syndrome within eight weeks of a previous influenza vaccine

6. anaphylactic reaction to gentamicin

7. anaphylactic reaction to gelatin

8. anaphylactic reaction to neomycin

9. anaphylactic reaction to arginine

10. pregnancy

11. household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)

12. use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

• 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

Responsibility Role: SPONSOR

Principal Investigators

Mark B Loeb, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

References

Loeb M, Russell ML, Manning V, Fonseca K, Earn DJ, Horsman G, Chokani K, Vooght M, Babiuk L, Schwartz L, Neupane B, Singh P, Walter SD, Pullenayegum E. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. 2016 Nov 1;165(9):617-624. doi: 10.7326/M16-0513. Epub 2016 Aug 16.

Reference Type: DERIVED

PMID: 27538259 (View on PubMed)

Other Identifiers

RC1-274129

Identifier Type: -

Identifier Source: org_study_id