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Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01653015
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : August 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent Inactivated Vaccine Biological: Live Attenuated Influenza Vaccine Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children
Actual Study Start Date : November 2012
Primary Completion Date : June 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Laboratory-confirmed influenza infection. [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Influenza like illness. [ Time Frame: December to June each year for 3 years. ]
  2. Physician diagnosed otitis media. [ Time Frame: December to June each year for 3 years. ]
  3. Antimicrobial prescriptions. [ Time Frame: December to June each year for 3 years. ]
  4. School or work related absenteeism. [ Time Frame: December to June each year for 3 years. ]
  5. Physician visits for respiratory illness. [ Time Frame: December to June each year for 3 years. ]
  6. Lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ]
  7. Hospitalization for lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ]
  8. All cause hospitalizations. [ Time Frame: December to June each year for 3 years. ]
  9. Deaths due to lower respiratory infections or pneumonia. [ Time Frame: December to June each year for 3 years. ]
  10. All cause deaths. [ Time Frame: December to June each year for 3 years. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653015


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mark B Loeb, MD, MSc McMaster University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01653015     History of Changes
Other Study ID Numbers: RC1-274129
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs