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

Abstract

Background 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. Methods Participants ( N = 50) received a 2-dose vaccination schedule. Solicited (collected daily: days 0 to 7 [post dose 1] and 21 to 28 [post dose 2]) and unsolicited (collected weekly until day 21) AEs were collected via diary cards. The QoL questionnaires were completed daily (days 0–6) and weekly (days 0, 6, 21, 27) after dose one. Questionnaire data were transformed into SF-6D scores to report QALDs. It was hypothesized post-hoc that the QALD and daily AEs scores should correlate if discrete QoL-changes were captured. Results 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). Conclusion 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. Trial registration ClinicalTrials.gov . NCT01788228. Registered 11 February 2013. Electronic supplementary material The online version of this article (10.1186/s12955-019-1147-4) contains supplementary material, which is available to authorized users.

Impact of Reactogenicity After Two Doses of Recombinant Zoster Vaccine Upon Physical Functioning and Quality of Life: An Open Phase III Trial in Older Adults

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Infant vaccination against pertussis in Argentina: Parent-reported outcomes on reactogenicity, impact on daily routine and satisfaction after pentavalent whole-cell or hexavalent acellular pertussis vaccines

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Integrating Alternative Social Value Judgments Into Cost-Effectiveness Analysis of Vaccines: An Application to Varicella-Zoster Virus Vaccination

“…33 These delayed outcomes are hard to assign to the first or the second dose. Therefore, given the explorative nature of this study, the QALY loss as a result of vaccination was included by proxy, as we applied a QALY loss measured in the first 21 days of an adjuvanted H5N1 vaccine, 34 which observed a QALY loss of 0.00011 QALYs per administered vaccine. As a secondary analysis we estimated our own side effect: a QALY loss of being for one day in EQ5D state 11121 (ie, perfect health but with moderate pain), which would be the equivalent of 0.00045 QALYs lost per dose.…”