Fluarix quadrivalent vaccine for influenza

Faust, Saul N

doi:10.1586/14760584.2015.1057573

Cited by 15 publications

(10 citation statements)

References 31 publications

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“…To address for the need for quadrivalent seasonal influenza vaccine, six kinds of quadrivalent seasonal influenza vaccines were developed and licensed to date: Flumist Quadrivalent of MedImmune, Fluarix Quadrivalent (QIV-008) and FluLaval Quadrivalent of GlaxoSmithKline, Fluzone Quadrivalent (GRC43) and Fluzone Intradermal Quadrivalent of Sanofi Pasteur, and Flucelvax of Seqirus Inc. [11][12][13][14][15] Comparing with the clinical trials results of those vaccines, NBP607-QIV showed comparable results in immunogenicity and safety. With the results, Korea Ministry of Food and Drug Safety (MFDS) authorized the use of NBP607-QIV in December 2015.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

Choi

Noh

Song

et al. 2017

Human Vaccines & Immunotherapeutics

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Background: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culturederived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects.Methods: A randomized controlled phase III trial was undertaken in 10 university hospitals in the Republic of Korea (Clinical trial Number-NCT02467842). Adults (aged 19-59 years) and elderly subjects (aged 60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months. AEs were sub-classified as adverse drug reactions (ADRs) according to the causality.Results: A total of 1,503 participants were randomly assigned to NBP607-QIV (n D 752), NBP607-Y (n D 373) and NBP607-V (n D 378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. A total of 730 reactions occurred in 324 (43.1%) subjects of NBP607-QIV group. Majority of ADRs was solicited (99.2%) and mild (90.3%) in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine within 3 weeks of vaccination and no vaccine-related SAEs were reported up to 6 months after vaccination.Conclusions: NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine in Korean adults and elderly subjects.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

Choi

Noh

Song

et al. 2017

Human Vaccines & Immunotherapeutics

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“…No efficacy studies have been published on the QIIV [ 15 ]. The efficacy of the QLAIV used in low-risk children has not yet been demonstrated in clinical trials.…”

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness analysis of quadrivalent seasonal influenza vaccines in England

Thorrington

Leeuwen

Ramsay

et al. 2017

BMC Med

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BackgroundAs part of the national seasonal influenza vaccination programme in England and Wales, children receive a quadrivalent vaccine offering protection against two influenza A strains and two influenza B strains. Healthy children receive a quadrivalent live attenuated influenza vaccine (QLAIV), whilst children with contraindications receive the quadrivalent inactivated influenza vaccine (QIIV). Individuals aged younger than 65 years in the clinical risk populations and elderly individuals aged 65+ years receive either a trivalent inactivated influenza vaccine (TIIV) offering protection from two A strains and one B strain or the QIIV at the choice of their general practitioner.The cost-effectiveness of quadrivalent vaccine programmes is an open question. The original analysis that supported the paediatric programme only considered a trivalent live attenuated vaccine (LAIV). The cost-effectiveness of the QIIV to other patients has not been established. We sought to estimate the cost-effectiveness of these programmes, establishing a maximum incremental total cost per dose of quadrivalent vaccines over trivalent vaccines.MethodsWe used the same mathematical model as the analysis that recommended the introduction of the paediatric influenza vaccination programme. The incremental cost of the quadrivalent vaccine is the additional cost over that of the existing trivalent vaccine currently in use.ResultsIntroducing quadrivalent vaccines can be cost-effective for all targeted groups. However, the cost-effectiveness of the programme is dependent on the choice of target cohort and the cost of the vaccines: the paediatric programme is cost-effective with an increased cost of £6.36 per dose, though an extension to clinical risk individuals younger than 65 years old and further to all elderly individuals means the maximum incremental cost is £1.84 and £0.20 per dose respectively.ConclusionsQuadrivalent influenza vaccines will bring substantial health benefits, as they are cost-effective in particular target groups.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0932-3) contains supplementary material, which is available to authorized users.

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“…The first QIV (a LAIV formulation) entered the market in 2012, and several other QIV formulations based on inactivated vaccine formulations, such as split and subunit formulations, have been licensed. The VE of QIV showed an immunogenicity and safety profile of the vaccine comparable with the two licensed trivalent vaccines containing the same strains 41 .…”

Section: Discussionmentioning

confidence: 79%

Molecular evolution of influenza B virus during 2011–2017 in Chaoyang, Beijing, suggesting the free influenza vaccine policy

Lei

Wang

Zhao

et al. 2019

Sci Rep

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Two influenza B virus lineages, B/Victoria and B/Yamagata, are co-circulating in human population. While the two lineages are serologically distinct and TIV only contain one lineage. It is important to investigate the epidemiological and evolutionary dynamics of two influenza B virus lineages in Beijing after the free influenza vaccine policy from 2007. Here, we collected the nasopharyngeal swabs of 12657 outpatients of influenza-like illness and subtyped by real-time RT-PCR during 2011–2017. The HA and NA genes of influenza B were fully sequenced. The prevalence is the highest in the 6–17 years old group among people infected with influenza B. Yamagata-lineage virus evolved to two inter-clade from 2011–2014 to 2014–2017. The amino acids substitutions of HA1 region were R279K in strains of 2011–2014 and L173Q, M252V in strains of 2014–2017. Substitutions L58P, I146V were observed in HA1 region of Victoria-lineage virus in 2011–2012 and I117V, N129D were showed in 2015–2017. Phylogenetic analysis of NA showed Yamagata-Victoria inter-lineage reassortant occurred in 2013–2014. Influenza B mainly infect the school-aged children in Beijing and the free influenza vaccine inoculation does not seem to block school-age children from infection with influenza B. The antigen characteristics of circulating influenza B were different to the recommended vaccine strains. We concluded that the Victoria-lineage vaccine strain should been changed and the free influenza vaccine should be revalued.

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Fluarix quadrivalent vaccine for influenza

Cited by 15 publications

References 31 publications

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

Cost-effectiveness analysis of quadrivalent seasonal influenza vaccines in England

Molecular evolution of influenza B virus during 2011–2017 in Chaoyang, Beijing, suggesting the free influenza vaccine policy

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