Immunogenicity and safety of cell-derived MF59®-adjuvanted A/H1N1 influenza vaccine for children

• Published in: Human vaccines & immunotherapeutics 2015-02, Vol.11 (2), p.358-376
• Main Authors: Knuf, Markus, Leroux-Roels, Geert, Rümke, Hans, Rivera, Luis, Pedotti, Paola, Arora, Ashwani Kumar, Lattanzi, Maria, Kieninger, Dorothee, Cioppa, Giovanni Della
• Format: Article
• Language: English
• Subjects: adjuvant; Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Adolescent; AE, adverse event; Antibodies, Viral - blood; cell-culture; Child; Child, Preschool; CHMP, European Committee for Medicinal Products for Human Use; CI, confidence interval; Female; GMR, geometric mean ratio; GMT, geometric mean titer; H1N1; Healthy Volunteers; Hemagglutination Inhibition Tests; HI, hemagglutination inhibition; Humans; Infant; Influenza A Virus, H1N1 Subtype - immunology; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza Vaccines - immunology; INFLUENZA/Research Papers; Male; MF59; MN, microneutralization; Neutralization Tests; pandemic; pediatric; Polysorbates - administration & dosage; Polysorbates - adverse effects; PPS, per-protocol set; SAE, serious adverse event; Single-Blind Method; Squalene - administration & dosage; Squalene - adverse effects; Vaccination - adverse effects; Vaccination - methods; WHO, World Health Organization
• ISSN: 2164-5515; 2164-554X
• DOI: 10.4161/21645515.2014.987014

Mass immunization of children has the potential to decrease infection rates and prevent the transmission of influenza. We evaluated the immunogenicity, safety, and tolerability of different formulations of cell-derived MF59-adjuvanted and nonadjuvanted A/H1N1 influenza vaccine in children and adolescents. This was a randomized, single-blind, multicenter study with a total of 666 healthy subjects aged 6 months-17 y in one of 3 vaccination groups, each receiving formulations containing different amounts of influenza A/H1N1 antigen with or without MF59. A booster trivalent seasonal MF59 vaccine was administered one year after primary vaccinations. Antibody titers were assessed by hemagglutination inhibition (HI) and microneutralization assays obtained on days 1, 22, 43, 366, and 387 (3 weeks post booster). Safety was monitored throughout the study. One vaccination with 3.75 μg of A/H1N1 antigen formulated with 50% MF59 (3.75_halfMF59) or 7.5 μg of A/H1N1 antigen formulated with 100% MF59 (7.5_fullMF59) induced an HI titer ≥1:40 in >70% of children in the 1-