Influenza symptoms and their impact on elderly adults: randomised trial of AS03‐adjuvanted or non‐adjuvanted inactivated trivalent seasonal influenza vaccines

Influenza and Other Respiratory Viruses

Gerrit A. van Essen⁸  Jiri Beran¹⁴  Jeanne-Marie Devaster¹⁵  Christelle Durand¹⁵  Xavier Duval⁶  Meral Esen¹⁰  Ann R. Falsey¹⁶  Gregory Feldman¹²  Pierre Gervais⁹  Bruce L. Innis¹¹  Martina Kovac¹⁵  Odile Launay^2,8  Geert Leroux-Roels^8,13  Janet E. McElhaney^4,8  Shelly McNeil^7,8  Mohammed Oujaa¹⁵  Jan Hendrik Richardus^1,8  Guillermo Ruiz-Palacios^5,8  Richard H. Osborne^3,8 

[1] GGD Rotterdam-Rijnmond, Rotterdam, The Netherlands;Inserm, CIC BT505, and National Network of Clinical Investigation in Vaccinology (REIVAC), Paris, France;Public Health Innovation, Population Health Strategic Research Centre, Deakin University, Melbourne, Australia;HSN Volunteer Association Chair in Geriatric Research, Advanced Medical Research Institute of Canada, Sudbury, ON, Canada;Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, México;Inserm CIC 007, U 738, Hôpital Bichat Claude Bernard, Paris, France;Queen Elizabeth Health Sciences Centre, Dalhousie University, PCIRN, NACI, CCfV, CAIRE, QEII HSC - VG Site Infectious Diseases, Halifax, NS, Canada;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands;Q&T Research Sherbrooke, Sherbrooke, QC, Canada;Institut für Tropenmedizin, Tübingen, Germany;GlaxoSmithKline Vaccines, King of Prussia, PA, USA;S. Carolina Pharmaceutical Research, Spartanburg, SC, USA;Centre for Vaccinology, Ghent University and Hospital, Ghent, Belgium;Vaccination and Travel Medicine Centre, Poliklinika 2, Czech Republic;GlaxoSmithKline Vaccines, Wavre, Belgium;University of Rochester Medical Center, Rochester, NY, USA

关键词: AS03‐adjuvanted vaccine;    elderly;    FluiiQ;    influenza;    patient‐reported outcomes;   

DOI  :  10.1111/irv.12245

来源: Wiley

【 摘 要 】

Abstract

Background

Patient-reported outcomes (PROs) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment.

Objectives

To evaluate PROs in people aged ≥65 years receiving two different vaccines.

Methods

This was a phase III, randomised, observer-blind study (NCT00753272) of the AS03-adjuvanted inactivated trivalent split-virion influenza vaccine (AS03-TIV) versus non-adjuvanted vaccine (TIV). Using the FluiiQ questionnaire, symptom (systemic, respiratory, total) and life impact (activities, emotions, relationships) scores were computed as exploratory endpoints, with minimal important difference (MID) in influenza severity between vaccines considered post-hoc as >7%. Vaccine efficacy of AS03-TIV relative to TIV in severe influenza (hospitalisation, complication, most severe one-third of episodes based on the area under the curve for systemic symptom score) was calculated post-hoc. The main analyses (descriptive) were conducted in the according-to-protocol cohort (n = 280 AS03-TIV, n = 315 TIV) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction.

Results

Mean systemic symptom, total symptom and impact on activities scores were lower with AS03-TIV versus TIV. Mean respiratory symptom, impact on emotions and impact on relationships scores were similar. Influenza tended to be less severe with AS03-TIV, but the MID was reached only for impact on activities (mean 9·0%). Relative vaccine efficacy in severe influenza was 29·38% (95% CI: 7·60–46·02).

Conclusions

AS03-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people. Higher efficacy of AS03-TIV relative to TIV was shown for prevention of severe illness.

【 授权许可】

CC BY   
© 2014 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.