Randomized Controlled Trial of LAIV vs TIV Vaccines in Schools

NCT01995851 | Completed DMC

• 1 other identifier: PCIRN PD05 ON07
• Study Type: observational
• Target: 902
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Vaccine

Outcome Measures

Primary Outcomes (1)

• Vaccine Uptake

  9 Months

Secondary Outcomes (1)

• Cost of school-based Influenza immunization clinics

  9 months

Other Outcomes (2)

• Incidence of laboratory-confirmed influenza

  9 months

• Public health, parental, and school board acceptance of programs

  9 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children from junior kindergarten to Grade 8, from 10 elementary schools will participate in this study.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dalhousie University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ontario Agency for Health Protection and Promotion: collaborator
• Peterborough County-City Health Unit: collaborator

Study Sites (1)

Public Health Ontario

Toronto, Ontario, Canada

Location

Related Publications (2)

• Kwong JC, Pereira JA, Quach S, Pellizzari R, Dusome E, Russell ML, Hamid JS, Feinberg Y, Winter AL, Gubbay JB, Sirtonski B, Moher D, Sider D, Finkelstein M, Loeb M; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Program Delivery and Evaluation Group. Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) cluster randomized trial: Pilot results from a household surveillance study to assess direct and indirect protection from influenza vaccination. Vaccine. 2015 Sep 11;33(38):4910-5. doi: 10.1016/j.vaccine.2015.07.044. Epub 2015 Jul 29.

  PMID: 26232348 DERIVED

• Kwong JC, Pereira JA, Quach S, Pellizzari R, Dusome E, Russell ML, Hamid JS, Feinberg Y, Winter AL, Gubbay JB, Sirtonski B, Moher D, Sider D, Finkelstein M, Loeb M; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Program Delivery and Evaluation Group. Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: a cluster randomized trial. Vaccine. 2015 Jan 15;33(4):535-41. doi: 10.1016/j.vaccine.2014.11.044. Epub 2014 Dec 6.

  PMID: 25488331 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Scott A Halperin, MD, PhD

  Nominated Principal Investigator, PHAC/CIHR Influenza Research Network (Dalhousie University)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nominated Prinicipal Investigator, PCIRN

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

CA (1)