Randomized Evaluation of Live Attenuated vs.Trivalent Inactivated Influenza Vaccines in Schools (RELATIVES)Pilot Study

Our study partnership (Public Health Agency of Canada [PHAC] / Canadian Institutes of Health Research [CIHR] Influenza Research Network [PCIRN], Public Health Ontario [PHO], and PCCHU), with the support of Ontario's Ministry of Health and Long-Term Care [MOHLTC], will conduct an open-label randomized trial in elementary schools within the geographic boundaries of PCCHU during the 2013-14 influenza vaccination campaign.

In order to address the four study objectives in our comparison of LAIV vs. TIV via SBII, we will use multiple methodologies: questionnaires, interviews, and household surveillance.

Overall study design PCCHU implemented SBII in elementary schools from 2000 to 2010, and we have approval from the Kawartha Pine Ridge District School Board (KPRDSB) to renew this program for the upcoming influenza season (2013-14). Ten schools (each school having an average of 300 students) will be recruited to participate in this study. The schools will be randomized on a 1:1 basis (i.e., five schools in each arm) to having its students offered (at no cost) 0.2 mL of LAIV or 0.5 mL of TIV at SBII clinics organized by PCCHU.

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. A 0.2 ml dose of the vaccine will be administered intranasally. TIV will also be available for children whose parents decline LAIV but would still like their child immunized against influenza, and for children who, according to 2012-13 NACI recommendations, have contraindications for LAIV: severe asthma (defined as currently on oral or high-dose inhaled glucocorticosteroids 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; and immune-compromising conditions due to underlying disease and/or therapy, as the vaccine contains live attenuated virus.

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. A 0.5 ml dose of the vaccine will be administered intramuscularly. Children with one or more of the following contraindications, according to NACI recommendations, will not be eligible for vaccination with TIV: 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.