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Health Qual Life Outcomes. 2019 May 6;17(1):80. doi: 10.1186/s12955-019-1147-4.

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.

Author information

1
GSK, 20 Avenue Fleming, 1300, Wavre, Belgium. BAUDOUIN.A.STANDAERT@GSK.COM.
2
Keyrus Management SA c/o GSK, Wavre, Belgium.
3
Present address: Biogen International GmbH, Baar, Switzerland.
4
GSK, Rockville, MD, USA.
5
Optimal Research LLC, Rockville, MD, USA.
6
Benchmark Research, Austin, TX, USA.
7
School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, USA.
8
Optum, Lincoln, RI, USA.
9
Seattle Women's: Health, Research, Gynecology, University of Washington, Seattle, WA, USA.
10
University of Wisconsin-Madison, Madison, WI, USA.
11
Eisai, Woodcliff Lake, NJ, USA.
12
Clinical Research Atlanta, Stockbridge, GA, USA.

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.

KEYWORDS:

Adjuvanted vaccine; Avian influenza A; H5N1; Quality of life; Reactogenicity; SF-36v2 questionnaire

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