Health-Related Quality of Life Following Administration of Influenza and COVID-19 Combination Vaccine in Older Adults: Results From a Phase 3 Randomized Controlled Trial
Author(s)
Darshan Mehta, MBA, PhD1, Matthias Hunger, MSc, PhD2, Shravan Kumar Adepu, MS3, Lusine Kostanyan, MD1, Benoit Callendret, PhD1, Deborah Rudin, MD1.
1Moderna, Cambridge, MA, USA, 2ICON Clinical Research, Muenchen, Germany, 3ICON Clinical Research, Bangalore, India.
1Moderna, Cambridge, MA, USA, 2ICON Clinical Research, Muenchen, Germany, 3ICON Clinical Research, Bangalore, India.
OBJECTIVES: Transient reductions in health-related quality of life (HRQoL) have been reported following administration of several currently available vaccines (e.g. influenza and shingles vaccines). mRNA-1083 is an investigational multi-component influenza and COVID-19 vaccine. This study evaluated short-term HRQoL changes within the first 7 days post-vaccination in older adults (≥65 years), including subgroups aged 65-74 and ≥75 years, in a Phase 3, randomized, observer-blind, active-controlled trial (NCT06097273).
METHODS: Participants (1:1 randomization) received either mRNA-1083 with placebo or co-administered Fluzone High-Dose Quadrivalent (HD-IIV4) and mRNA-1273 (Spikevax). HRQoL outcomes were assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, completed daily from baseline (Day 1, pre-vaccination) through Day 7. The analysis population included all safety-evaluable participants with a baseline EQ-5D-5L score. U.S. utility index values were calculated using the Pickard et al. tariff. A linear mixed model for repeated measures assessed changes in EQ-5D-5L utility scores over time by vaccine group. Based on Henry et al. a change greater than 0.078 was considered minimally important difference (MID) i.e. representing smallest change in health status considered meaningful.
RESULTS: On Day 2 post-vaccination, participants in both groups reported a modest decline in EQ-5D-5L utility scores (mRNA-1083:-0.043 (95% CI: -0.047, -0.039) co-administration: -0.023 (95% CI:-0.027, -0.019)). Similar declines were observed in the 65-74 (mRNA-1083: -0.043 (95% CI:-0.047, -0.038) co-administration: -0.024 (95% CI:-0.028, -0.019)) and ≥75 (mRNA-1083: -0.044 (95% CI:-0.055, -0.033) co-administration: -0.023 (95% CI:-0.034, -0.012)) age subgroups. The observed decline on day 2 was less than the instrument defined MID. There was no difference in EQ-5D-5L utility scores across both groups, overall, in 65+ and in subgroups, from days 4 to 7.
CONCLUSIONS: mRNA-1083 was associated with a transient and minor decrements in participants' HRQoL, which were not meaningful. These findings are consistent with other currently licensed vaccines and support the tolerability of mRNA-1083 from a patient-reported outcomes perspective.
METHODS: Participants (1:1 randomization) received either mRNA-1083 with placebo or co-administered Fluzone High-Dose Quadrivalent (HD-IIV4) and mRNA-1273 (Spikevax). HRQoL outcomes were assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, completed daily from baseline (Day 1, pre-vaccination) through Day 7. The analysis population included all safety-evaluable participants with a baseline EQ-5D-5L score. U.S. utility index values were calculated using the Pickard et al. tariff. A linear mixed model for repeated measures assessed changes in EQ-5D-5L utility scores over time by vaccine group. Based on Henry et al. a change greater than 0.078 was considered minimally important difference (MID) i.e. representing smallest change in health status considered meaningful.
RESULTS: On Day 2 post-vaccination, participants in both groups reported a modest decline in EQ-5D-5L utility scores (mRNA-1083:-0.043 (95% CI: -0.047, -0.039) co-administration: -0.023 (95% CI:-0.027, -0.019)). Similar declines were observed in the 65-74 (mRNA-1083: -0.043 (95% CI:-0.047, -0.038) co-administration: -0.024 (95% CI:-0.028, -0.019)) and ≥75 (mRNA-1083: -0.044 (95% CI:-0.055, -0.033) co-administration: -0.023 (95% CI:-0.034, -0.012)) age subgroups. The observed decline on day 2 was less than the instrument defined MID. There was no difference in EQ-5D-5L utility scores across both groups, overall, in 65+ and in subgroups, from days 4 to 7.
CONCLUSIONS: mRNA-1083 was associated with a transient and minor decrements in participants' HRQoL, which were not meaningful. These findings are consistent with other currently licensed vaccines and support the tolerability of mRNA-1083 from a patient-reported outcomes perspective.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR114
Topic
Epidemiology & Public Health, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Vaccines