Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03
Adjuvants, Immunologic
/ administration & dosage
Adult
Female
Humans
Influenza A Virus, H5N1 Subtype
/ immunology
Influenza Vaccines
/ administration & dosage
Influenza, Human
/ prevention & control
Male
Middle Aged
Quality of Life
/ psychology
Surveys and Questionnaires
Time Factors
Vaccination
/ adverse effects
Adjuvanted vaccine
Avian influenza A
H5N1
Quality of life
Reactogenicity
SF-36v2 questionnaire
Journal
Health and quality of life outcomes
ISSN: 1477-7525
Titre abrégé: Health Qual Life Outcomes
Pays: England
ID NLM: 101153626
Informations de publication
Date de publication:
06 May 2019
06 May 2019
Historique:
received:
02
03
2018
accepted:
25
04
2019
entrez:
8
5
2019
pubmed:
8
5
2019
medline:
7
6
2019
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.
Identifiants
pubmed: 31060567
doi: 10.1186/s12955-019-1147-4
pii: 10.1186/s12955-019-1147-4
pmc: PMC6501410
doi:
Substances chimiques
Adjuvants, Immunologic
0
Influenza Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT01788228']
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
80Subventions
Organisme : Biomedical Advanced Research and Development Authority
ID : HHSO100200700029C
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