Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza vaccine in young children and adults 65 years of age and older. (August 2019)

• Record Type: Journal Article
• Authors: Lindert, Kelly; Leav, Brett; Heijnen, Esther; Barrett, Julia; Nicolay, Uwe
• Is Part Of: International journal of infectious diseases. Volume 85(2019)Supplement 1
• Page Start: S10
• Page End: S17
• Publication Date: 2019-08
• Subjects: Safety -- MF59 -- Adjuvant -- Influenza -- Vaccine -- Elderly; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2019.03.020
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Safety of aIIV3 was analyzed with a large clinical trial and surveillance dataset. aIIV3 and comparator were associated with similar AE rates. In revaccination studies, aIIV3 AEs increased in Year 2 but decreased in Year 3. No evidence suggests aIIV3 is associated with higher risk of immune-mediated AEs. Abstract: Objective: To assess the long-term safety of MF59-adjuvanted trivalent influenza vaccine (aIIV3; Fluad™) in adults ≥65 years of age. Methods: Data from 36 primary vaccination and 7 re-vaccination Phase I through III trials were analyzed; 7532 subjects received aIIV3 and 5198 subjects a nonadjuvanted trivalent inactivated influenza vaccine (IIV3). These trials were evaluated in 2 data poolings: first-dose randomized controlled trials (FD-RCT) and revaccination trials. Spontaneously reported adverse events (AEs) from post-marketing surveillance were also analyzed. Results: The percentages of subjects reporting AEs following vaccination were similar between aIIV3 and IIV3: 24.8% for aIIV3 vs 26.7% for IIV3 (relative risk [RR] 0.94; 95% confidence interval [CI] 0.87–1.01). The percentage of subjects with serious AEs was 6.7% for aIIV3 vs 7.0% for IIV3 (RR 0.95; 95% CI 0.82–1.09). Percentages of subjects with AEs leading to withdrawal, hospitalizations, adverse events of special interest (AESIs), and deaths between vaccination groups were similar. There was no signal of disproportionality for AESIs associated with aIIV3 compared to IIV3 in the post-marketing database. Conclusions: This integrated safety analysis demonstrates an acceptable safety profile for aIIV3 in adults ≥65 years of age.