• Ann. Intern. Med. · Nov 2016

    Randomized Controlled Trial

    Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial.

    • Mark Loeb, Margaret L Russell, Vanessa Manning, Kevin Fonseca, David J D Earn, Gregory Horsman, Khami Chokani, Mark Vooght, Lorne Babiuk, Lisa Schwartz, Binod Neupane, Pardeep Singh, Stephen D Walter, and Eleanor Pullenayegum.
    • From McMaster University, Hamilton, Ontario; University of Calgary, Calgary, Alberta; Saskatchewan Disease Control Laboratory, Regina, Saskatchewan; Prince Albert Parkland Health Region, Prince Albert, Saskatchewan; Five Hills Health Region, Moose Jaw, Saskatchewan; and Hospital for Sick Children, Toronto, Ontario, Canada.
    • Ann. Intern. Med. 2016 Nov 1; 165 (9): 617-624.

    BackgroundWhether vaccinating children with intranasal live attenuated influenza vaccine (LAIV) is more effective than inactivated influenza vaccine (IIV) in providing both direct protection in vaccinated persons and herd protection in unvaccinated persons is uncertain. Hutterite colonies, where members live in close-knit, small rural communities in which influenza virus infection regularly occurs, offer an opportunity to address this question.ObjectiveTo determine whether vaccinating children and adolescents with LAIV provides better community protection than IIV.DesignA cluster randomized blinded trial conducted between October 2012 and May 2015 over 3 influenza seasons. (ClinicalTrials.gov: NCT01653015).Setting52 Hutterite colonies in Alberta and Saskatchewan, Canada.Participants1186 Canadian children and adolescents aged 36 months to 15 years who received the study vaccine and 3425 community members who did not.InterventionChildren were randomly assigned according to community in a blinded manner to receive standard dosing of either trivalent LAIV or trivalent IIV.MeasurementsThe primary outcome was reverse transcriptase polymerase chain reaction-confirmed influenza A or B virus in all participants (vaccinated children and persons who did not receive the study vaccine).ResultsMean vaccine coverage among children in the LAIV group was 76.9% versus 72.3% in the IIV group. Influenza virus infection occurred at a rate of 5.3% (295 of 5560 person-years) in the LAIV group versus 5.2% (304 of 5810 person-years) in the IIV group. The hazard ratio comparing LAIV with IIV for influenza A or B virus was 1.03 (95% CI, 0.85 to 1.24).LimitationThe study was conducted in Hutterite communities, which may limit generalizability.ConclusionImmunizing children with LAIV does not provide better community protection against influenza than IIV.Primary Funding SourceThe Canadian Institutes for Health Research.

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