Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects

• Published in: Vaccine Vol. 32; no. 39; pp. 5027 - 5034
• Main Authors: Frey, Sharon E., Reyes, Mari Rose Aplasca-De Los, Reynales, Humberto, Bermal, Nancy Nazaire, Nicolay, Uwe, Narasimhan, Vas, Forleo-Neto, Eduardo, Arora, Ashwani Kumar
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 03.09.2014; Elsevier; Elsevier Limited
• Subjects: Adjuvant; Adjuvants, Immunologic - pharmacology; Age; Aged; Allergy and Immunology; antibodies; Antibodies, Viral - blood; Antibody Formation; Antigens; Applied microbiology; Biological and medical sciences; Confidence intervals; Elderly; Female; Fundamental and applied biological sciences. Psychology; Hemagglutination Inhibition Tests; Humans; immune response; Immunization; Immunogenicity; Influenza; Influenza A Virus, H3N2 Subtype; Influenza vaccine; Influenza Vaccines - immunology; Influenza Vaccines - therapeutic use; Influenza, Human - prevention & control; Male; MF59; Microbiology; Non-inferiority; Polysorbates - pharmacology; Population; Ratios; Single-Blind Method; Squalene - pharmacology; Superiority; vaccination; Vaccine Potency; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); United States > US; RR; TIV; HI; AE; ILI; aTIV; GMT; PPS; CBER; SAE; Non-inferiority; CHMP; MF59; FAS; HA; Adjuvant; Influenza vaccine; Elderly; Superiority; full analysis set; trivalent influenza vaccine; hemagglutinin; adjuvanted trivalent influenza vaccine; influenza-like illness; geometric mean titer; serious adverse event; per-protocol set; adverse event; relative risk; European Committee for Medicinal Products for Human Use; Center for Biologics Evaluation and Research; hemagglutinin inhibition; Human; Vaccine; Infection; Immunogenicity; Viral disease; Immunological adjuvant; Influenza A

•Non-adjuvanted influenza vaccines elicit a poor response in the elderly.•Adjuvanted and non-adjuvanted vaccines were compared in 7082 elderly subjects.•Adjuvanted influenza vaccine elicited a significantly higher antibody response.•Adjuvant enhanced antibody responses in subjects with underlying me...