IS THE SF-6D DAILY SENSITIVE TO CAPTURE QALD-VARIATION ON REACTOGENICITY OF INJECTABLE VACCINES?
Author(s)
Meier G1, Kosinski M2, Dort T3, Madan A4, Standaert B5, Schuind A4
1Eisai, Woodcliff Lake, NJ, USA, 2Optum, Lincoln, RI, USA, 3Keyrus Management S.A. on behalf of GSK Vaccines, Strombeek-Bever, Belgium, 4GSK Vaccines, Collegeville, PA, USA, 5GSK Vaccines, Wavre, Belgium
OBJECTIVES: Injectable adjuvanted vaccines cause local reactogenicity which may temporarily impact the Quality of Life (QoL) of vaccinated individuals. Variation in QoL-change expressed as quality-adjusted life day (QALD)-scores can be assessed with validated questionnaires used at regular time points capturing the health states of vaccinees. METHODS: Adult subjects (N=50) received a 2-dose vaccination schedule of an AS03-adjuvanted H5N1 pandemic influenza vaccine. At Day0 (just before the injection) and during the next 6 days (post-injection) subjects completed the SF-36 questionnaire with a 24 hours recall period (ClinicalTrials.gov Identifier: NCT01788228). Data were analyzed to obtain a QALD-score using the same algorithm as for the transformation of the SF-36 weekly questionnaire into a SF-6D being considered an appropriate QALD-score measure. During the same period, local and general symptoms were evaluated for each participant on a daily basis. It was hypothesized that the QALD-scores and the symptom scores were to correlate, if the former instrument was able to capture appropriately QALD-variation. RESULTS: Questionnaires were filled in with an average rate of compliance of 98%. The daily sum of local (pain, redness, swelling) and general (fatigue, gastrointestinal symptoms, headache, arthralgia, myalgia, chill, sweating, fever) symptoms scores were 90 (Day0), 127 (Day1), 99 (Day2), 41 (Day3), 28 (Day4), 12 (Day5), and 4 (Day6). The average QALD-scores were 0.885 (Day0), 0.860 (Day1), 0.874 (Day2), 0.887 (Day3), 0.893 (Day4), 0.901 (Day5), and 0.902 (Day6). The correlation coefficient between the two scores was -0.952 (p<0.001). CONCLUSIONS: We observed that symptom scores slightly increased for the first 2 days post-vaccination, and QALD-scores reflect and are able to capture that change. Noteworthy is that the QALD-loss on reactogenicity of the adjuvanted vaccine was marginal in time and score (-0.020/day during 2 days) which supports the tolerability of the H5N1 AS03-adjuvanted vaccine.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PRM128
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Infectious Disease (non-vaccine)