Background: Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria. Methods: A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly with a standard-dose, egg-grown, quadrivalent-inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18-49 years of age. The coprimary endpoints for noninferiority were hemagglutination inhibition seroconversion rates and postvaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for 7 days, other safety events collected for 28 days, and serious or medically attended adverse events collected for 6 months after vaccination comprised the safety evaluation. Results: The immunogenicity of RIV4 was comparable to that of IIV4; the coprimary noninferiority criteria were met for 3 antigens, and the antibody responses to the fourth antigen, influenza B/Brisbane/60/2008, were low in each group, making comparisons uninterpretable. Systemic and injection site reactions were mild, transient, and similar in each group, whereas none of the spontaneously reported adverse events, serious or nonserious, were considered related to study vaccine. Conclusions: This first head-to-head comparison of recombinant versus inactivated quadrivalent influenza vaccines in 18-49 year old adults showed comparable immunogenicity, safety, and tolerability for both vaccines.
RCT Entities:
Background: Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria. Methods: A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly with a standard-dose, egg-grown, quadrivalent-inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18-49 years of age. The coprimary endpoints for noninferiority were hemagglutination inhibition seroconversion rates and postvaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for 7 days, other safety events collected for 28 days, and serious or medically attended adverse events collected for 6 months after vaccination comprised the safety evaluation. Results: The immunogenicity of RIV4 was comparable to that of IIV4; the coprimary noninferiority criteria were met for 3 antigens, and the antibody responses to the fourth antigen, influenza B/Brisbane/60/2008, were low in each group, making comparisons uninterpretable. Systemic and injection site reactions were mild, transient, and similar in each group, whereas none of the spontaneously reported adverse events, serious or nonserious, were considered related to study vaccine. Conclusions: This first head-to-head comparison of recombinant versus inactivated quadrivalent influenza vaccines in 18-49 year old adults showed comparable immunogenicity, safety, and tolerability for both vaccines.
Authors: Carole Henry; Anna-Karin E Palm; Henry A Utset; Min Huang; Irvin Y Ho; Nai-Ying Zheng; Theresa Fitzgerald; Karlynn E Neu; Yao-Qing Chen; Florian Krammer; John J Treanor; Andrea J Sant; David J Topham; Patrick C Wilson Journal: J Virol Date: 2019-10-15 Impact factor: 5.103
Authors: John Hansen; Kristin Goddard; Julius Timbol; Lea Zhang; Ned Lewis; Lisa Dunkle; Ruvim Izikson; Nicola P Klein Journal: Open Forum Infect Dis Date: 2020-05-20 Impact factor: 3.835
Authors: Surender Khurana; Megan Hahn; Elizabeth M Coyle; Lisa R King; Tsai-Lien Lin; John Treanor; Andrea Sant; Hana Golding Journal: Nat Commun Date: 2019-07-26 Impact factor: 14.919
Authors: Alice Mannocci; Andrea Pellacchia; Rossella Millevolte; Manuela Chiavarini; Chiara de Waure Journal: Int J Environ Res Public Health Date: 2022-08-01 Impact factor: 4.614