MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico.
The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014-2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV. Seroconversion was one of several secondary objectives. In total, 287 children were enrolled. The non-inferiority criteria for GMTs and seroconversion were met for aTIV for all 3 vaccine strains. Lower bounds of the 95% confidence intervals for all 3 aTIV:TIV vaccine ratios were >2, showing that the immunogenicity of aTIV was superior to that of TIV for all 3 strains. Solicited adverse events (AEs) were experienced more frequently with aTIV than TIV by younger children (aged 6 to <36 months), but were more frequent with TIV than aTIV in older children (aged 36 to <72 months) who had been vaccinated previously. More unsolicited AEs were associated with aTIV than the TIV. All AEs were of mild or moderate severity. No deaths, serious AEs, or AEs leading to premature withdrawal were reported. Overall, aTIV was highly immunogenic and was well tolerated in healthy children 6 to <72 months of age. These results indicate that aTIV may be a beneficial addition to national pediatric vaccination programs.
['Cruz-Valdez|Aurelio|A|', 'Valdez-Zapata|Gabriel|G|', 'Patel|Sanjay S|SS|', 'Castelli|Flavia V|FV|', 'Garcia|Marcia G|MG|', 'Jansen|Wim T|WT|', 'Arora|Ashwani Kumar|AK|', 'Heijnen|Esther|E|']
D000276:Adjuvants, Immunologic D002675:Child, Preschool D005260:Female D006801:Humans D007211:Indoles D007223:Infant D053118:Influenza A Virus, H1N1 Subtype D053122:Influenza A Virus, H3N2 Subtype D009981:Influenza B virus D007252:Influenza Vaccines D007251:Influenza, Human D008297:Male D008800:Mexico D013453:Sulfonylurea Compounds
influenza trivalent influenza vaccine adjuvant immunogenicity safety MF59