Please use this identifier to cite or link to this item: https://hdl.handle.net/10356/80335
Title: The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial
Authors: Young, Barnaby
Sadarangani, Sapna
Yew, Haur Sen
Yung, Chee Fu
Leo, Yee Sin
Chen, Mark I-Cheng
Wilder-Smith, Annelies
Keywords: Influenza
Vaccine
Issue Date: 2017
Source: Young, B., Sadarangani, S., Yew, H. S., Yung, C. F., Leo, Y. S., Chen, M. I.-C., et al. (2017). The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial. Trials, 18(67).
Series/Report no.: Trials
Abstract: Background: The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore. Methods/design: This is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360. Discussion: If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint. Trial registration: ClinicalTrials.gov, ID: NCT02655874. Registered on 12 January 2016.
URI: https://hdl.handle.net/10356/80335
http://hdl.handle.net/10220/42142
ISSN: 1745-6215
DOI: http://dx.doi.org/10.1186/s13063-017-1808-8
Rights: © 2017 The Author(s). Open Access This 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.
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:LKCMedicine Journal Articles

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