PMID- 31060567 OWN - NLM STAT- MEDLINE DCOM- 20190606 LR - 20200225 IS - 1477-7525 (Electronic) IS - 1477-7525 (Linking) VI - 17 IP - 1 DP - 2019 May 6 TI - Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study. PG - 80 LID - 10.1186/s12955-019-1147-4 [doi] LID - 80 AB - 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. FAU - Standaert, B AU - Standaert B AD - GSK, 20 Avenue Fleming, 1300, Wavre, Belgium. BAUDOUIN.A.STANDAERT@GSK.COM. FAU - Dort, T AU - Dort T AD - Keyrus Management SA c/o GSK, Wavre, Belgium. AD - Present address: Biogen International GmbH, Baar, Switzerland. FAU - Linden, J AU - Linden J AD - GSK, Rockville, MD, USA. FAU - Madan, A AU - Madan A AD - GSK, Rockville, MD, USA. FAU - Bart, S AU - Bart S AD - Optimal Research LLC, Rockville, MD, USA. FAU - Chu, L AU - Chu L AD - Benchmark Research, Austin, TX, USA. FAU - Hayney, M S AU - Hayney MS AD - School of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, USA. FAU - Kosinski, M AU - Kosinski M AD - Optum, Lincoln, RI, USA. FAU - Kroll, R AU - Kroll R AD - Seattle Women's: Health, Research, Gynecology, University of Washington, Seattle, WA, USA. FAU - Malak, J AU - Malak J AD - University of Wisconsin-Madison, Madison, WI, USA. FAU - Meier, G AU - Meier G AD - Eisai, Woodcliff Lake, NJ, USA. FAU - Segall, N AU - Segall N AD - Clinical Research Atlanta, Stockbridge, GA, USA. FAU - Schuind, A AU - Schuind A AD - GSK, Rockville, MD, USA. LA - eng SI - ClinicalTrials.gov/NCT01788228 GR - HHSO100200700029C/Biomedical Advanced Research and Development Authority/ PT - Journal Article PT - Validation Study DEP - 20190506 PL - England TA - Health Qual Life Outcomes JT - Health and quality of life outcomes JID - 101153626 RN - 0 (Adjuvants, Immunologic) RN - 0 (Influenza Vaccines) SB - IM MH - Adjuvants, Immunologic/administration & dosage/*adverse effects MH - Adult MH - Female MH - Humans MH - Influenza A Virus, H5N1 Subtype/immunology MH - Influenza Vaccines/administration & dosage/*adverse effects MH - Influenza, Human/*prevention & control MH - Male MH - Middle Aged MH - Quality of Life/*psychology MH - Surveys and Questionnaires MH - Time Factors MH - Vaccination/adverse effects/psychology PMC - PMC6501410 OTO - NOTNLM OT - Adjuvanted vaccine OT - Avian influenza A OT - H5N1 OT - Quality of life OT - Reactogenicity OT - SF-36v2 questionnaire COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice. The research and all appropriate documentation were reviewed and approved by the Independent Ethics Committee or the Institutional Review Board (Chesapeake Research Review Inc., Columbia, MD, USA and Western Institutional Review Boards, Puyllup, WA, USA). Written informed consent was obtained from each participant before the performance of any study-specific procedures. CONSENT FOR PUBLICATION: Not applicable as no individual patient data is reported. COMPETING INTERESTS: SB, JM, LC, and MK have nothing to disclose. MH, NS and RK report their organization received funding from the GSK group of companies to complete the work disclosed in this manuscript. MH and NS also report funding from Sanofi or the GSK group of company for activities outside the submitted work. GM was previously an employee of the GSK group of company, and she held shares in the GSK group of companies. TD reports consulting fees to his institution at the time of the study, Keyrus Management SA, from the GSK group of companies. AM, AS, BS and JL are employees of the GSK group of company; AM, AS, and BS hold shares in the GSK group of companies. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2019/05/08 06:00 MHDA- 2019/06/07 06:00 PMCR- 2019/05/06 CRDT- 2019/05/08 06:00 PHST- 2018/03/02 00:00 [received] PHST- 2019/04/25 00:00 [accepted] PHST- 2019/05/08 06:00 [entrez] PHST- 2019/05/08 06:00 [pubmed] PHST- 2019/06/07 06:00 [medline] PHST- 2019/05/06 00:00 [pmc-release] AID - 10.1186/s12955-019-1147-4 [pii] AID - 1147 [pii] AID - 10.1186/s12955-019-1147-4 [doi] PST - epublish SO - Health Qual Life Outcomes. 2019 May 6;17(1):80. doi: 10.1186/s12955-019-1147-4.