Overview

This trial is active, not recruiting.

Condition influenza
Treatments trivalent inactivated vaccine, live attenuated influenza vaccine
Phase phase 4
Sponsor McMaster University
Collaborator Canadian Institutes of Health Research (CIHR)
Start date November 2012
End date December 2015
Trial size 3800 participants
Trial identifier NCT01653015, RC1-274129

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Live attenuated influenza vaccine (LAIV).
trivalent inactivated vaccine VAXIGRIP by Sanofi Pasteur
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.
(Active Comparator)
Trivalent inactivated vaccine (TIV).
live attenuated influenza vaccine FLUMIST by Mediummune.
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.

Primary Outcomes

Measure
Laboratory-confirmed influenza infection.
time frame: up to 3 years

Secondary Outcomes

Measure
Influenza like illness.
time frame: December to June each year for 3 years.
Physician diagnosed otitis media.
time frame: December to June each year for 3 years.
Antimicrobial prescriptions.
time frame: December to June each year for 3 years.
School or work related absenteeism.
time frame: December to June each year for 3 years.
Physician visits for respiratory illness.
time frame: December to June each year for 3 years.
Lower respiratory infection or pneumonia.
time frame: December to June each year for 3 years.
Hospitalization for lower respiratory infection or pneumonia.
time frame: December to June each year for 3 years.
All cause hospitalizations.
time frame: December to June each year for 3 years.
Deaths due to lower respiratory infections or pneumonia.
time frame: December to June each year for 3 years.
All cause deaths.
time frame: December to June each year for 3 years.

Eligibility Criteria

Male or female participants of any age.

Group A: Inclusion criteria: - healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention. 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: Inclusion Criteria - other Hutterite community members that are not in Group A Exclusion Criteria: - there are no exclusion criteria for this category of participants

Additional Information

Official title A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
Principal investigator Mark B Loeb, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by McMaster University.