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Randomized Controlled Trial of LAIV vs TIV Vaccines in Schools (RELATIVES)

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: NCT01995851
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ontario Agency for Health Protection and Promotion
Peterborough County-City Health Unit
Information provided by (Responsible Party):
Scott Halperin, Dalhousie University

Brief Summary:
Overall, this study will determine (1) the effect of vaccine type (FluMist vs. TIV) on immunization rates, (2) assess the feasibility of school immunization clinics, and (3) inform a larger study to understand the effects of these two vaccines on reducing influenza.

Condition or disease
Influenza

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Study Type : Observational
Estimated Enrollment : 902 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Evaluation of Live Attenuated vs.Trivalent Inactivated Influenza Vaccines in Schools (RELATIVES)Pilot Study
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort
Intervention (LAIV)
Healthy children and adolescents between Junior Kindergarten (JK) and Grade 8 in the intervention schools will be immunized with LAIV (FluMist influenza vaccine) recommended for the 2013-14 the influenza season.
Control (TIV)
Healthy children and adolescents between JK and Grade 8 in schools assigned to TIV will be immunized with inactivated influenza vaccine (Vaxigrip vaccine) recommended for the 2013-14 influenza season.



Primary Outcome Measures :
  1. Vaccine Uptake [ Time Frame: 9 Months ]

Secondary Outcome Measures :
  1. Cost of school-based Influenza immunization clinics [ Time Frame: 9 months ]

Other Outcome Measures:
  1. Incidence of laboratory-confirmed influenza [ Time Frame: 9 months ]
  2. Public health, parental, and school board acceptance of programs [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children from junior kindergarten to Grade 8, from 10 elementary schools will participate in this study.
Criteria
Children in schools randomized to LAIV cannot receive this vaccine if they have any of the following contraindications: severe asthma (defined as currently on oral or high-dose inhaled glucocorticosteriods or active wheezing) or medically attended wheezing in the 7 days prior to vaccination; receiving aspirin or aspirin-containing therapy because of the association of Reye's syndrome with aspirin and wild-type influenza infection; or immune-compromising conditions due to underlying disease and/or therapy, as the vaccine contains live attenuated virus. These children will receive TIV instead, unless they have a contraindication to receiving TIV. Children in schools assigned to TIV cannot receive this vaccine if they have any of the following contraindications: an anaphylactic reaction to a previous dose; an anaphylactic reaction to any of the vaccine components, with the exception of egg; or Guillain-Barré Syndrome (GBS) within six weeks of a previous influenza vaccination.

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): NCT01995851


Locations
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Canada, Ontario
Public Health Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Dalhousie University
Canadian Institutes of Health Research (CIHR)
Ontario Agency for Health Protection and Promotion
Peterborough County-City Health Unit
Investigators
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Study Director: Scott A Halperin, MD, PhD Nominated Principal Investigator, PHAC/CIHR Influenza Research Network (Dalhousie University)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott Halperin, Nominated Prinicipal Investigator, PCIRN, Dalhousie University
ClinicalTrials.gov Identifier: NCT01995851    
Other Study ID Numbers: PCIRN PD05 ON07
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Scott Halperin, Dalhousie University:
Influenza
Vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases