A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses

• Published in: Vaccine Vol. 36; no. 40; pp. 6030 - 6038
• Main Authors: van de Witte, Serge, Nauta, Jos, Montomoli, Emanuele, Weckx, Jos
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 25.09.2018; Elsevier Limited
• Subjects: Adult; Age; Aged; antibodies; Antibodies, Neutralizing - blood; Antibodies, Viral - blood; Antigens; Conflicts of interest; cumulative distribution; elderly; Epidemics; Europe; Female; geometry; Geriatrics; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins, Influenza Virus - immunology; Hemagglutinins; Humans; Immune response; Immune system; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulins; Influenza; Influenza A virus - immunology; Influenza B virus; Influenza vaccine; influenza vaccines; Influenza Vaccines - adverse effects; Influenza Vaccines - classification; Influenza Vaccines - immunology; Influenza, Human - prevention & control; Male; Middle Aged; neutralization tests; Older people; Quadrivalent; Randomization; Safety; Seroconversion; Strains (organisms); Vaccines; Vaccines, Inactivated - adverse effects; Vaccines, Inactivated - immunology; Vaccines, Subunit - adverse effects; Vaccines, Subunit - immunology; Virus neutralisation; Viruses; Europe; Virus neutralisation; Quadrivalent; Safety; Immunogenicity; Influenza vaccine

•The immunogenicity of QIV was non-inferior to the matched influenza strains in TIV.•The immunogenicity of QIV was superior to the alternate-lineage B-strains in TIV.•The results of the HI assay correlated with the results of VN assay.•QIV was well tolerated with a similar safety profile to that of...