Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03A-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study

This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily...

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Bibliographic Details
Published in:Health and quality of life outcomes 2019-05, Vol.17 (1), p.80-80, Article 80
Main Authors: Standaert, B, Dort, T, Linden, J, Madan, A, Bart, S, Chu, L, Hayney, M. S, Kosinski, M, Kroll, R, Malak, J, Meier, G, Segall, N, Schuind, A
Format: Article
Language:English
Subjects:
Adjuvanted vaccine
Analysis
Antigens
Avian flu
Avian influenza
Avian influenza A
Comparative analysis
Complications and side effects
Correlation analysis
Correlation coefficient
Correlation coefficients
H5N1
Influenza
Influenza A
Influenza vaccines
Medical research
Muscles
Pain
Pandemics
Quality of life
Questionnaires
Reactogenicity
Safety
Safety and security measures
Schedules
SF-36v2 questionnaire
Studies
Systematic review
Vaccination
Vaccines
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Summary:This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily to record changes over seven days. A more sensitive application of this instrument should allow for a better understanding of short-term tolerability of adjuvanted vaccines. Pain (92%) and muscle ache (66%) were the most commonly reported solicited local and general AEs respectively, neither increased in intensity nor in frequency after dose 2. No safety concerns were identified during the study. A correlation between the daily AEs and QALD scores existed (correlation coefficient, - 0.97 (p < 0.001)). The impact of the AEs scores on the QALD was marginal (- 0.02 max for one day). Similarly with other H5N1 studies, no safety concern was identified throughout the study. Some time-limited variations in QALD-scores were reported. Our results imply that daily administration of the SF-36v2 captures changes in QALD-scores.
ISSN:1477-7525
1477-7525
DOI:10.1186/s12955-019-1147-4