Efficacy of a Russian-backbone live attenuated influenza vaccine among young children in Bangladesh: a randomised, double-blind, placebo-controlled trial

W Abdullah Brooks, K Zaman, Kristen D C Lewis, Justin R Ortiz, Doli Goswami, Jodi Feser, Amina Tahia Sharmeen, Kamrun Nahar, Mustafizur Rahman, Mohammed Ziaur Rahman, Burc Barin, Muhammad Yunus, Alicia M Fry, Joseph Bresee, Tasnim Azim, Kathleen M Neuzil, W Abdullah Brooks, K Zaman, Kristen D C Lewis, Justin R Ortiz, Doli Goswami, Jodi Feser, Amina Tahia Sharmeen, Kamrun Nahar, Mustafizur Rahman, Mohammed Ziaur Rahman, Burc Barin, Muhammad Yunus, Alicia M Fry, Joseph Bresee, Tasnim Azim, Kathleen M Neuzil

Abstract

Background: The rates of influenza illness and associated complications are high among children in Bangladesh. We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine (LAIV) at two field sites in Bangladesh.

Methods: Between Feb 27 and April 9, 2013, children aged 2-4 years in urban Kamalapur and rural Matlab, Bangladesh, were randomly assigned in a 2:1 ratio, according to a computer-generated schedule, to receive one intranasal dose of LAIV or placebo. After vaccination, we monitored children in weekly home visits until Dec 31, 2013, with study clinic surveillance for influenza illness. The primary outcome was symptomatic, laboratory-confirmed influenza illness due to vaccine-matched strains. Analysis was per protocol. The trial is registered with ClinicalTrials.gov, number NCT01797029.

Findings: Of 1761 children enrolled, 1174 received LAIV and 587 received placebo. Laboratory-confirmed influenza illness due to vaccine-matched strains was seen in 93 (15·8%) children in the placebo group and 79 (6·7%) in the LAIV group. Vaccine efficacy of LAIV for vaccine-matched strains was 57·5% (95% CI 43·6-68·0). The vaccine was well tolerated, and adverse events were balanced between the groups. The most frequent adverse events were tachypnoea (n=86 in the LAIV group and n=54 in the placebo group), cough (n=73 and n=43), and runny nose (n=68 and n=39), most of which were mild.

Interpretation: This single-dose Russian-backbone LAIV was safe and efficacious at preventing symptomatic laboratory-confirmed influenza illness due to vaccine-matched strains. LAIV programmes might reduce the burden of influenza illness in Bangladesh.

Funding: The Bill & Melinda Gates Foundation.

Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Figures

Figure 1
Figure 1
Trial profile LAIV=live attenuated influenza vaccine.
Figure 2
Figure 2
Influenza circulation in the study area overall and in Kamalapur and Matlab, by type and subtype or lineage, in weeks 9–52 of 2013 (A) The whole study area. (B) Kamalapur. (C) Matlab. Circulating and vaccine B strains were mismatched and, therefore, did not contribute to vaccine efficacy

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