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; 7,532 subjects received aIIV3 and 5,198 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.