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Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by McMaster University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01653015
First received: July 26, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Trivalent Inactivated Vaccine
Biological: Live Attenuated Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Laboratory-confirmed influenza infection. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influenza like illness. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Physician diagnosed otitis media. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Antimicrobial prescriptions. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • School or work related absenteeism. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Physician visits for respiratory illness. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Hospitalization for lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • All cause hospitalizations. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • Deaths due to lower respiratory infections or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
  • All cause deaths. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 3800
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine LAIV
Live attenuated influenza vaccine (LAIV).
Biological: 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.
Other Name: VAXIGRIP by Sanofi Pasteur
Active Comparator: Influenza vaccine TIV
Trivalent inactivated vaccine (TIV).
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.
Other Name: FLUMIST by Mediummune.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653015

Contacts
Contact: Vanessa EA Manning, CCRA 905-525-9140 ext 26678 manninv@mcmaster.ca
Contact: Sasha Eskandarian 905-525-9140 ext 26672 eskand@mcmaster.ca

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Mark B Loeb, MD, MSc    905-525-9140 ext 26066    loebm@mcmaster.ca   
Contact: Vanessa EA Manning, CCRA    905-525-9140 ext 26678    manninv@mcmaster.ca   
Principal Investigator: Mark B Loeb, MD, MSc         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mark B Loeb, MD, MSc McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01653015     History of Changes
Other Study ID Numbers: RC1-274129
Study First Received: July 26, 2012
Last Updated: October 20, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014