tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2017 Oct 2:0. doi: 10.1080/21645515.2017.1384106. [Epub ahead of print]
[h=1]Safety, immunogenicity, and lot-to-lot consistency of a split-virion quadrivalent influenza vaccine in younger and older adults: a phase III randomized, double-blind clinical trial.[/h] Sesay S[SUP]1[/SUP], Brzostek J[SUP]2[/SUP], Meyer I[SUP]3[/SUP], Donazzolo Y[SUP]4[/SUP], Leroux-Roels G[SUP]5[/SUP], Rouzier R[SUP]6[/SUP], Astruc B[SUP]7[/SUP], Szymanski H[SUP]8[/SUP], Toursarkissian N[SUP]9[/SUP], Vandermeulen C[SUP]10[/SUP], Kowalska E[SUP]11[/SUP], Van Damme P[SUP]12[/SUP], Salamand C[SUP]13[/SUP], Pepin S[SUP]14[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Here, we report a randomized multicenter phase III trial assessing the lot-to-lot consistency of the 2014-2015 Northern Hemisphere quadrivalent split-virion inactivated influenza vaccine (IIV4; Sanofi Pasteur) and comparing its immunogenicity and safety with that of trivalent inactivated influenza vaccine (IIV3) in younger and older adults (EudraCT no. 2014-000785-21). Younger (18-60 y, n = 1114) and older (>60 y, n = 1111) adults were randomized 2:2:2:1:1 to receive a single dose of one of three lots of IIV4, the licensed IIV3 containing the B Yamagata lineage strain, or an investigational IIV3 containing the B Victoria lineage strain. Post-vaccination (day 21) hemagglutination inhibition antibody titers were equivalent for the three IIV4 lots. For the pooled IIV4s vs. IIV3, hemagglutination inhibition antibody titers were also non-inferior for the A strains, non-inferior for the B strain when present in the comparator IIV3, and superior for the B strain lineage when absent from the comparator IIV3. For all vaccine strains, seroprotection rates were ≥98% in younger adults and ≥90% in older adults. IIV4 also increased seroneutralizing antibody titers against all three vaccine strains of influenza. All vaccines were well tolerated, with no safety concerns identified. Solicited injection-site reactions were similar for IIV4 and IIV3 and mostly grade 1 and transient. This study showed that in younger and older adults, IIV4 had a similar safety profile as the licensed IIV3 and that including a second B strain lineage in IIV4 provided superior immunogenicity for the added B strain without affecting the immunogenicity of the three IIV3 strains.
[h=4]KEYWORDS:[/h] adult; elderly; immunogenicity; inactivated influenza vaccine; quadrivalent influenza vaccine; randomized controlled trial; safety
PMID: 28968138 DOI: 10.1080/21645515.2017.1384106
[h=1]Safety, immunogenicity, and lot-to-lot consistency of a split-virion quadrivalent influenza vaccine in younger and older adults: a phase III randomized, double-blind clinical trial.[/h] Sesay S[SUP]1[/SUP], Brzostek J[SUP]2[/SUP], Meyer I[SUP]3[/SUP], Donazzolo Y[SUP]4[/SUP], Leroux-Roels G[SUP]5[/SUP], Rouzier R[SUP]6[/SUP], Astruc B[SUP]7[/SUP], Szymanski H[SUP]8[/SUP], Toursarkissian N[SUP]9[/SUP], Vandermeulen C[SUP]10[/SUP], Kowalska E[SUP]11[/SUP], Van Damme P[SUP]12[/SUP], Salamand C[SUP]13[/SUP], Pepin S[SUP]14[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Here, we report a randomized multicenter phase III trial assessing the lot-to-lot consistency of the 2014-2015 Northern Hemisphere quadrivalent split-virion inactivated influenza vaccine (IIV4; Sanofi Pasteur) and comparing its immunogenicity and safety with that of trivalent inactivated influenza vaccine (IIV3) in younger and older adults (EudraCT no. 2014-000785-21). Younger (18-60 y, n = 1114) and older (>60 y, n = 1111) adults were randomized 2:2:2:1:1 to receive a single dose of one of three lots of IIV4, the licensed IIV3 containing the B Yamagata lineage strain, or an investigational IIV3 containing the B Victoria lineage strain. Post-vaccination (day 21) hemagglutination inhibition antibody titers were equivalent for the three IIV4 lots. For the pooled IIV4s vs. IIV3, hemagglutination inhibition antibody titers were also non-inferior for the A strains, non-inferior for the B strain when present in the comparator IIV3, and superior for the B strain lineage when absent from the comparator IIV3. For all vaccine strains, seroprotection rates were ≥98% in younger adults and ≥90% in older adults. IIV4 also increased seroneutralizing antibody titers against all three vaccine strains of influenza. All vaccines were well tolerated, with no safety concerns identified. Solicited injection-site reactions were similar for IIV4 and IIV3 and mostly grade 1 and transient. This study showed that in younger and older adults, IIV4 had a similar safety profile as the licensed IIV3 and that including a second B strain lineage in IIV4 provided superior immunogenicity for the added B strain without affecting the immunogenicity of the three IIV3 strains.
[h=4]KEYWORDS:[/h] adult; elderly; immunogenicity; inactivated influenza vaccine; quadrivalent influenza vaccine; randomized controlled trial; safety
PMID: 28968138 DOI: 10.1080/21645515.2017.1384106