tetano
Editor, Senior Moderator
J Infect Dis. 2017 Sep 9. doi: 10.1093/infdis/jix478. [Epub ahead of print]
[h=1]Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age.[/h] Dunkle LM[SUP]1[/SUP], Izikson R[SUP]1[/SUP], Patriarca PA[SUP]2[/SUP], Goldenthal KL[SUP]3[/SUP], Muse D[SUP]4[/SUP], Cox MMJ[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria.
[h=4]Methods:[/h] A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly to a standard-dose egg-grown, quadrivalent inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18-49 years of age. The co-primary endpoints for non-inferiority were hemagglutination inhibition seroconversion rates and post-vaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for seven days, other safety events collected for 28 days, and serious or medically-attended adverse events collected for six months after vaccination comprised the safety evaluation.
[h=4]Results:[/h] The immunogenicity of RIV4 was comparable to that of IIV4; the co-primary non-inferiority criteria were met for three 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, while none of the spontaneously-reported adverse events, serious or non-, were considered related to study vaccine.
[h=4]Conclusions:[/h] 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.
[h=4]ClinicalTrials.gov:[/h] #NCT02290509.
[h=4]KEYWORDS:[/h] Comparative immunogenicity; Flublok Quadrivalent; Recombinant influenza vaccine
PMID: 28968871 DOI: 10.1093/infdis/jix478
[h=1]Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age.[/h] Dunkle LM[SUP]1[/SUP], Izikson R[SUP]1[/SUP], Patriarca PA[SUP]2[/SUP], Goldenthal KL[SUP]3[/SUP], Muse D[SUP]4[/SUP], Cox MMJ[SUP]1[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Seasonal influenza vaccines are transitioning to quadrivalent formulations including the hemagglutinins of influenza A subtypes H1N1 and H3N2 and B lineages Yamagata and Victoria.
[h=4]Methods:[/h] A new quadrivalent recombinant influenza vaccine (RIV4) was compared directly to a standard-dose egg-grown, quadrivalent inactivated influenza vaccine (IIV4) for immunogenicity and safety in adults 18-49 years of age. The co-primary endpoints for non-inferiority were hemagglutination inhibition seroconversion rates and post-vaccination geometric mean titer ratios for each antigen using US regulatory criteria. Reactogenicity solicited for seven days, other safety events collected for 28 days, and serious or medically-attended adverse events collected for six months after vaccination comprised the safety evaluation.
[h=4]Results:[/h] The immunogenicity of RIV4 was comparable to that of IIV4; the co-primary non-inferiority criteria were met for three 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, while none of the spontaneously-reported adverse events, serious or non-, were considered related to study vaccine.
[h=4]Conclusions:[/h] 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.
[h=4]ClinicalTrials.gov:[/h] #NCT02290509.
[h=4]KEYWORDS:[/h] Comparative immunogenicity; Flublok Quadrivalent; Recombinant influenza vaccine
PMID: 28968871 DOI: 10.1093/infdis/jix478