MF59-adjuvanted seasonal trivalent inactivated influenza vaccine: Safety and immunogenicity in young children at risk of influenza complications.

Abstract

OBJECTIVE\nTo assess the safety and immunogenicity of the MF59-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad) in children aged 6 months through 5 years who are at risk of influenza complications.\n\n\nMETHODS\nA retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated dataset from six randomized clinical studies that compared aIIV3 with non-adjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised 10\u2009784 children, of whom 373 (3%) were at risk of influenza complications.\n\n\nRESULTS\nThe at-risk safety population comprised 373 children aged 6 months through 5 years: 179 received aIIV3 and 194 received non-adjuvanted IIV3 (128 subjects received a licensed IIV3). The most important risk factors were respiratory system illnesses (62-70%) and infectious and parasitic diseases (33-39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk children and 55% of healthy children who received aIIV3; of those receiving licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited AE. The most common AEs were infections, including upper respiratory tract infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 participants from one study), geometric mean titers (GMTs) were approximately 2- to 3-fold higher with aIIV3 than with IIV3 for all three homologous strains (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79-96%) and IIV3 (83-89%).\n\n\nCONCLUSIONS\nIn young children at risk of influenza complications, aIIV3 was well-tolerated and had a safety profile that was generally similar to that of non-adjuvanted IIV3. Similar to the not-at-risk population, the immune response in at-risk subjects receiving aIIV3 was increased over those receiving IIV3, suggesting aIIV3 is a valuable option in young children at risk of influenza complications.