Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III, randomized trial

• Published in: Vaccine Vol. 32; no. 13; pp. 1480 - 1487
• Main Authors: Tinoco, Juan Carlos, Pavia-Ruz, Noris, Cruz-Valdez, Aurelio, Aranza Doniz, Carlos, Chandrasekaran, Vijayalakshmi, Dewé, Walthère, Liu, Aixue, Innis, Bruce L., Jain, Varsha K.
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 14.03.2014; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; adults; Aged; Aged, 80 and over; Allergy and Immunology; antibodies; Antibodies, Viral - blood; Antibody Formation; Applied microbiology; Biological and medical sciences; confidence interval; Confidence intervals; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Hemagglutination Inhibition Tests; Humans; immune response; Immunization; Immunogenicity; Inactivated quadrivalent influenza vaccine; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza B virus; Influenza Vaccines - classification; Influenza Vaccines - therapeutic use; Influenza, Human - prevention & control; Male; Microbiology; Middle Aged; Public health; Safety; Seasonal influenza; Seasons; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Inactivated - therapeutic use; Victoria lineage; Yamagata lineage; Young Adult; Australia; Victoria; Oceania; United States > US; TIV; HI; MAEs; SCR; CDC; CI; Inactivated quadrivalent influenza vaccine; TIV-Vic; GMT; AEs; CBER; SPR; Victoria lineage; TIV-Yam; SCF; Seasonal influenza; HA; SAEs; Yamagata lineage; ATP; QIV; WHO; Hemagglutinin; According to protocol; Hemagglutination inhibition; Serious adverse events; TIV-B Yamagata; World Health Organization; inactivated trivalent influenza vaccine; adverse events; Center for Disease Control and Prevention; TIV-B Victoria; Geometric mean titer; Seroconversion rate; Seroprotection rate; confidence interval; medically attended events; Center for Biologics Evaluation and Research; seroconversion factor; Infection; Phase III trial; Immunogenicity; Toxicity; Viral disease; Influenza; Inactivated strain
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2014.01.022

•Immunogenicity of QIV was non-inferior versus TIV for shared strains in adults.•Immunogenicity of QIV was superior to TIV for the alternate-lineage B strain in adults.•Reactogenicity and safety of QIV consistent with seasonal influenza vaccine in adults. Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.