Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza vaccine in young children and adults 65 years of age and older
| Autor: | Julia Barrett, Uwe Nicolay, Esther Heijnen, Kelly Lindert, Brett Leav |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Male
Squalene 0301 basic medicine Microbiology (medical) Trivalent influenza vaccine Pediatrics medicine.medical_specialty Influenza vaccine 030106 microbiology Immunization Secondary MF59 Polysorbates lcsh:Infectious and parasitic diseases law.invention 03 medical and health sciences 0302 clinical medicine Adjuvants Immunologic Randomized controlled trial law Influenza Human medicine Humans lcsh:RC109-216 030212 general & internal medicine Mortality Adverse effect Aged Randomized Controlled Trials as Topic Clinical Trials as Topic business.industry General Medicine Confidence interval Hospitalization Vaccination Infectious Diseases Vaccines Inactivated Influenza Vaccines Child Preschool Relative risk Female Seasons business |
| Zdroj: | International Journal of Infectious Diseases, Vol 85, Iss, Pp S10-S17 (2019) |
| ISSN: | 1201-9712 |
| DOI: | 10.1016/j.ijid.2019.03.020 |
| Popis: | 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. Keywords: Safety, MF59, Adjuvant, Influenza, Vaccine, Elderly |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|