(P-325) Comparison of Safety Profiles by Chronic Health Conditions in Korean Adults with Egg-based Inactivated Quadrivalent Influenza Vaccines (QIV, GC3110A)

Background: Previous studies have found that adults aged 65 years and older, and chronic diseases such as asthma, heart disease, stroke and diabetes are at higher risk of developing serious complications from influenza infection. The United States Centers for Disease Control and Prevention (US CDC) recommends influenza vaccination expecially for elderly and adults with certain chronic health conditions. However, there are only a few studies of comparing QIV safety profiles in adults with and without chronic health conditions.

Objectives: To compare safety profiles of an egg-based inactivated QIV (GC3110A) in adults with and without chronic health conditions.

Methods:

Design: A secondary data analysis with data from GC3110A clinical trials (NCT02352584, NCT02917304).
Setting: We assessed safety in adults (≥19 years) with (n=202) and without chronic health conditions (n=719). Chronic health conditions included vascular disorder including hypertension, metabolism and nutrition disorders including diabetes, respiratory disorders including asthma, and cardiac disorders.
Exposure: Vaccination of QIV
Main outcome measures: Safety profiles were assessed for 21 days post-vaccination: solicited adverse event (AE) and adverse drug reaction (ADR) for 7 days and unsolicited AE and ADR for 21 days. Total AEs and ADRs were analyzed.
Statistical analysis: t-test, Chi-square test

Results: Among 921 Korean adults (≥19 years), 202 adults had one or more chronic health conditions, while 719 adults had not any of the chronic health conditions. Age and body mass index (BMI) were significantly higher in adults with chronic health conditions than in adults without chronic health conditions (mean age (SD): 63.3 (12.7) vs 44.6 (16.9), p<0.0001; mean BMI (SD): 24.8 (3.37) vs 23.3 (3.08), p<0.0001) at baseline characteristics. Both AEs (47.5% vs 61.6%, p=0.0034) and ADRs (52.5% vs 63.8%, p=0.0003) were significantly less frequent in adults with chronic health conditions. In sub-analyses, both AEs (51.6% vs 63.3%, p=0.0069) and ADRs (47.1% vs 60.8%, p=0.0016) were significantly lower in adults with vascular disorders. There were no significant differences in AEs and ADRs between adults with and without the chronic health condition for metabolism and nutrition disorders, respiratory disorders, and cardiac disorders. The above results will be confirmed afrter controlling for age and BMI.

Conclusions: Both AEs and ADRs of QIV-GC3110A were generally similar in Korean adults with and without common chronic health conditions, although they were less frequent in adults with vascular disorders than in adults without vascular disorders.