Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

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.

Timeline

Start

2012-11

Primary completion

2015-06

Completion

2015-12

Publications

• Loeb M, Russell ML, Manning V, Fonseca K, Earn DJ, Horsman G, Chokani K, Vooght M, Babiuk L, Schwartz L, Neupane B, Singh P, Walter SD, Pullenayegum E. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. 2016 Nov 1;165(9):617-624. doi: 10.7326/M16-0513. Epub 2016 Aug 16.

Drugs

Indications