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Secondary outcomes

BY Barnaby Young
SS Sapna Sadarangani
HY Haur Sen Yew
CY Chee Fu Yung
YL Yee Sin Leo
MC Mark I-Cheng Chen
AW Annelies Wilder-Smith
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The secondary outcomes are as follows:

Comparison by vaccination group of Geometric Mean Titres (GMTs) against homologous and heterologous influenza strains from day 208 to day 360

Comparison by vaccination group of the Geometric Mean Ratio (GMR) of HI titres post versus pre-vaccination (day 1), against homologous and heterologous strains from day 208 to day 360

Comparison by vaccination group of seroprotection rates (HI titre ≥1:40) against homologous and heterologous strains from day 208 to day 360

Comparison by vaccination group of participants with seroconversion against homologous and heterologous strains from day 208 to day 360 (seroconversion is defined as a pre-vaccination (day 1) HI titre <10 and post-vaccination HI titre ≥40 or at least a four-fold increase in HI titres from a pre-vaccination HI titre ≥10)

Comparison by vaccination group of MN titres against homologous and heterologous strains from day 208 to day 360

Number of participants reporting ILI across vaccine groups from day 208 to day 360

Number of participants with PCR-confirmed influenza across vaccine groups from day 208 to day 360

Number of participants reporting healthcare utilisation (emergency room visits, unscheduled physician visits, and hospitalisations in each group) across vaccine groups from day 180 to day 360

All-cause mortality rate, across vaccine groups from day 180 to day 360

Frequency and severity of solicited local (injection site) and systemic AEs for 7 days post vaccination. The frequency of the following AEs will be reported per regulatory guidance (CPMP/BWP214/96): indurations larger than 50 mm in diameter and persisting for more than 3 days, ecchymosis, temperature >38 °C for 24 h or more, malaise, shivering

Percentage of participants with SAE from day 1 to day 360

Copyright and License information: The Author(s). ©2017
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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