Background The cell-propagated inactivated quadrivalent influenza vaccine (ccIIV4) may offer improved protection in seasons where egg-derived influenza viruses undergo mutations that affect antigenicity. This study estimated the relative vaccine effectiveness (rVE) of ccIIV4 versus egg-derived inactivated quadrivalent influenza vaccine (eIIV4) in preventing influenza-related medical encounters in the 2018-2019 U.S. season. Methods A dataset linking primary care electronic medical records with medical claims data was used to conduct a retrospective cohort study among individuals ≥4 years vaccinated with ccIIV4 or eIIV4 during the 2018-2019 season. Adjusted odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, geographic region, vaccination week, and health status. Relative vaccine effectiveness (rVE) was estimated by (1-OR)*100 and presented with 95% confidence intervals (CI). Results Following the application of inclusion/exclusion criteria, the study cohort included 2,125,430 ccIIV4 and 8,000,903 eIIV4 recipients. Adjusted analyses demonstrated a greater reduction in influenza-related medical encounters with ccIIV4 versus eIIV4, with the following rVE: overall, 7.6% (95% CI 6.5-8.6); age 4-17 years, 3.9% (0.9-7.0); 18-64 years, 6.5% (5.2-7.9); 18-49 years, 7.5% (5.7-9.3); 50-64 years, 5.6% (3.6-7.6); and ≥65 years, -2.2% (-5.4 to 0.9). Conclusions Adjusted analyses demonstrated statistically significantly greater reduction in influenza-related medical encounters in individuals vaccinated with ccIIV4 vs eIIV4 in the 2018-2019 U.S. influenza season. These results support ccIIV4 as a potentially more effective public health measure against influenza than an egg-based equivalent.

Background The effectiveness of standard, egg-derived quadrivalent influenza vaccines (IIV4) may be reduced in adults ≥65 years of age, largely due to immunosenescence. An MF59®-adjuvanted trivalent influenza vaccine (aIIV3) and a high-dose trivalent influenza vaccine (HD-IIV3) offer older adults enhanced protection versus standard vaccines. This study compared the relative effectiveness of aIIV3 to IIV4 and HD-IIV3 in preventing influenza-related medical encounters over two US influenza seasons. Methods This retrospective cohort study included US patients ≥65 years vaccinated with aIIV3, IIV4, or HD-IIV3. The outcome of interest was the occurrence of influenza-related medical encounters. Data were derived from a large dataset comprised of primary and specialty care electronic medical records linked with pharmacy and medical claims. Adjusted odds ratios (OR) were derived from an inverse probability of treatment-weighted sample adjusted for age, sex, race, ethnicity, geographic region, vaccination week, and health status. Relative vaccine effectiveness (rVE) was determined using the formula (% VE =1-ORadjusted)*100. Results In 2017-2018, cohorts included: aIIV3, n=524,223; IIV4, n=917,609; HD-IIV3, n=3,377,860. After adjustment, 2017-2018 rVE of aIIV3 vs. IIV4 was 18.2 (95% confidence interval [CI] 15.8 to 20.5); aIIV3 vs. HD-IIV3 was 7.7 (2.3 to 12.8). In 2018-2019, cohorts included: aIIV3, n=1,031,145; IIV4, n=915,380; HD-IIV3, n=3,809,601, with adjusted rVEs of aIIV3 vs. IIV4 of 27.8 (25.7 to 29.9) and vs. HD-IIV3 of 6.9 (3.1 to 10.6). Conclusion In the 2017-2018 and 2018-2019 influenza seasons in the US, aIIV3 demonstrated greater reduction in influenza-related medical encounters than IIV4 and HD-IIV3 in adults ≥65 years.

Background Age-related immunosenescence may impair the immune response to vaccination in older adults. Adjuvanted influenza vaccines are designed to overcome immune senescence in older adults. This study estimated the relative vaccine effectiveness (rVE) of MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) versus egg-derived quadrivalent inactivated influenza vaccine (IIV4e) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) in preventing influenza-related medical encounters in the 2019-2020 US season. Methods This retrospective cohort study used electronic medical records linked to pharmacy and medical claims data. The study population included adults age ≥65 years with a record of aIIV3, IIV4e, or HD-IIV3 vaccination. A doubly robust inverse probability of treatment weighting model was used to derive adjusted odds ratios (OR). rVE was calculated by (1–ORadjusted)*100 and was determined overall and separately for age subgroups. An exploratory analysis evaluated the outcome separately in inpatient and outpatient settings. Results Subjects received aIIV3 (n=936,508), IIV3e (n=651,034), and HD-IIV3 (n=1,813,819) and influenza-related medical encounters were recorded in 0.5%, 0.9%, 0.7% of each cohort, respectively. Overall, rVE of aIIV3 was 27.5% (95% CI, 24.4 to 30.5) versus IIV4e and 13.9% (95% CI 10.7 to 17.0) vs versus HD-IIV3. aIIV3 had a more favorable rVE in inpatient and outpatient settings. Findings remained consistent across age subgroups and during alternative seasonal dates. Conclusions Adults ≥65 years vaccinated with aIIV3 had fewer influenza-related medical encounters compared with IIV4e or HD-IIV3 during the 2019-2020 US influenza season.

Introduction: IDegLira is a fixed-ratio combination of insulin degludec and liraglutide indicated for the treatment of type 2 diabetes (T2D). We report the first real-world study describing change in glycated hemoglobin (HbA1c) among US patients who initiated IDegLira. The aim of the study was to observe and describe changes in glycemic control and weight in patients initiating IDegLira in real-world clinical practice. Methods: Patients in the Practice Fusion electronic medical record database who initiated treatment with IDegLira between March 2017 and June 2018 were identified (n = 1384). To be included in the analyses, the study population needed to meet age, time in database pre-and post-initiation, and availability of HbA1c data at baseline and follow-up requirements. Data were analyzed according to baseline therapy subgroups and whether patients were intensifying (primary analysis group) or simplifying (secondary analysis group) their diabetes treatment. Changes in clinical outcomes from baseline were evaluated by paired t tests and linear regression. Results: The overall study population comprised 296 patients, of whom 206 were included in the primary analysis group and 90 were included in the secondary analysis group. In the adjusted analyses, there was a reduction in HbA1c of-1.1% in the primary analysis group, with the HbA1c reduction in all prior therapy groups ranging from-0.8% for those previously on basal insulin to-1.0% for those previously on non-injectable therapy (p \ 0.0001 for all). In a similar adjusted analysis, there was a statistically significant but small (1.0 lb/0.45 kg) change in weight in the primary analysis group. In the secondary analysis, patients previously on more than one injection daily switched to a more simplified therapy without compromising on glycemic control (HbA1c change of-0.16%). Conclusion: Consistent with previous realworld studies, IDegLira lowered HbA1c across different background prior glucose-lowering therapies, with minimal impact on weight.

Background Individuals with health conditions have shown higher rates of influenza-related morbidity and mortality compared to healthy individuals and are often prioritized for influenza vaccination. However, vaccination with egg-derived standard quadrivalent inactivated influenza vaccines (IIV4) has shown to be less effective in adults ≥65 years of age largely due to immunosenecence. Two enhanced vaccines, the MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and a high-dose trivalent inactivated influenza vaccine (HD-IIV3), were developed to provide adults ≥65 years with increased protection. The objective of this study was to determine the relative vaccine effectiveness (rVE) of aIIV3 versus IIV4 and HD-IIV3 in preventing influenza-related medical encounters in high-risk adults ≥65 years. Methods A retrospective cohort study was conducted among adults ≥65 years with ≥1 health condition with a record of receiving either aIIV3, IIV4 or HD-IIV3 in the 2017–18 or 2018–19 influenza seasons. Patient-level electronic medical records linked to pharmacy and medical claims were used to ascertain exposure, outcome and covariate information. The primary outcome was influenza-related medical encounters in primary care and hospital (ICD-10 codes J09*–J11*). Inverse probability of treatment weighting was used to obtain odds ratios (ORs) adjusted for age, sex, race, ethnicity, geographic region, comorbidities and week of vaccination for each health condition. rVE was determined using the formula (1-OR)*100 and reported with 95% confidence intervals (CI). Results Overall, 1,755,420 individuals with ≥1 health condition were included for analysis in the 2017–18 season and 2,055,012 individuals in the 2018–19 season. In both seasons, high-risk subjects who received aIIV3 had statistically significantly greater reduction in influenza-related medical encounters as compared to IIV4 (Table 1). Non-statistically significant estimates preclude definitive conclusions for comparisons with HD-IIV3. Table 1. Adjusted relative vaccine effectiveness (rVE) of aIIV3 versus comparators in high-risk patients in the 2017–2018 and 2018–2019 influenza seasons in the U.S. Conclusion The results of this study support the use of aIIV3 in adults ≥65 years of age at high risk for influenza complications and provides further evidence supporting aIIV3 as an effective public health measure against influenza. Disclosures Lauren Fischer, M.A., Seqirus (Consultant) Dan O'Brien, BA, Seqirus (Consultant) Joseph Vasey, PhD, Seqirus (Consultant) Gregg C. Sylvester, MD, Seqirus (Employee) James A. Mansi, PhD, Seqirus (Employee)