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

Abstract

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.

Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged ≥ 6 months in India

“…The lowest post-/pre-vaccination titer ratios and seroconversion rates were associated with high baseline titers, especially vs. A(H1N1) and A(H3N2) in participants aged 3-8 and 9-17 years. As found in other studies of inactivated influenza vaccines, [16][17][18] post-vaccination titers decreased with age.…”

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial

“…Consistent with studies in non-pregnant adults, 30,32,33 IIV4 induced similar HAI antibody titers to IIV3 in pregnant women for the three common vaccine strains, and higher HAI titers for the additional B lineage strain. Baseline HAI antibody titers for A/H1N1 and B/Yamagata were high in the study population.…”

Impfen im Alter – Pflicht oder Kür?

“…Beim zellkulturbasierten Herstellungsverfahren müssen die Impfviren nicht mehr für die Vermehrung in Hühnereiern adaptiert werden, was zu Hämagglutinin-Veränderungen im Impfstoff mit veränderter Wirksamkeit führt. Die daraus resultierende hohe Übereinstimmung der Impfstoffbestandteile mit den saisonalen Viren sorgt für eine gute Wirksamkeit [5].…”