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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy of a Russian-backbone live attenuated influenza vaccine among children in Senegal: a randomised, double-blind, placebo-controlled trial
The Lancet Global Health, Volume 4, No. 12, Year 2016
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Description
Background Live attenuated influenza vaccines have been shown to significantly reduce influenza in diverse populations of children, but no efficacy studies have been done in resource-poor tropical settings. In Senegal, we assessed the efficacy and safety of a live attenuated influenza vaccine based on Russian-derived master donor viruses and licensed as a single dose. Methods In this double-blind, placebo-controlled, parallel group, single-centre trial done near Niakhar, Senegal, generally healthy children aged 2–5 years were randomly allocated (2:1) to receive a single intranasal dose of masked trivalent live attenuated influenza vaccine or placebo. The allocation sequence was computer-generated by PATH with block sizes of three. The manufacturer provided vaccine and placebo in coded vials to preserve blinding. Participants were monitored through the predictable influenza season in Senegal for adverse events and signs and symptoms of influenza using weekly home visits and surveillance in clinics. The primary outcome was symptomatic laboratory-confirmed influenza caused by any strain and occurring from 15 days post-vaccination to the end of the study. The primary analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT01854632. Findings Between May 23, and July 1, 2013, 1761 children were randomly assigned, 1174 to receive live attenuated influenza vaccine and 587 to receive placebo. The per-protocol set included 1173 vaccinees and 584 placebo recipients followed up to Dec 20, 2013. Symptomatic influenza was laboratory-confirmed in 210 (18%) of 1173 recipients of live attenuated influenza vaccine and 105 (18%) of placebo recipients, giving a vaccine efficacy of 0·0% (95% CI −26·4 to 20·9). Adverse events were balanced between the study groups. Two girls who had received live attenuated influenza vaccine died, one due to anasarca 12 days postvaccination and one due to malnutrition 70 days postvaccination. Interpretation Live attenuated influenza vaccine was well tolerated in young children in Senegal, but did not provide protection against influenza. Further study in such populations, which might experience extended periods of influenza circulation, is warranted. Funding US Centers for Disease Control and Prevention and Bill & Melinda Gates Foundation. © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC5118222/bin/mmc1.pdf
Authors & Co-Authors
Victor, John C.
United States, Seattle
Path Seattle
Lewis, Kristen D.C.
United States, Seattle
Path Seattle
Diallo, Aldiouma M.
France, Marseille
Ird Institut de Recherche Pour le Developpement
Niang, Mbayame N’Diaye D.
Unknown Affiliation
Diarra, Bou
France, Marseille
Ird Institut de Recherche Pour le Developpement
Dia, Ndongo D.
Unknown Affiliation
Ortiz, Justin R.
United States, Seattle
Path Seattle
United States, Seattle
University of Washington
Widdowson, Marc Alain
United States, Atlanta
Centers for Disease Control and Prevention
Feser, Jodi
United States, Seattle
Path Seattle
Emery, Shannon L.
United States, Atlanta
Centers for Disease Control and Prevention
Lafond, Kathryn E.
United States, Atlanta
Centers for Disease Control and Prevention
Neuzil, Kathleen Maletic
United States, Baltimore
University of Maryland School of Medicine
Statistics
Citations: 44
Authors: 12
Affiliations: 5
Identifiers
Doi:
10.1016/S2214-109X(16)30201-7
ISSN:
2214109X
Research Areas
Disability
Food Security
Health System And Policy
Maternal And Child Health
Study Locations
Senegal
Participants Gender
Female