Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III, randomized trial

Tinoco, Juan Carlos; Pavía-Ruz, Noris; Cruz-Valdéz, Aurelio; Doniz, Carlos Aranza; Chandrasekaran, Vijayalakshmi; Dewé, Walthère; Liu, Aixue; Innis, Bruce L.; Jain, Varsha

doi:10.1016/j.vaccine.2014.01.022

Cited by 70 publications

(54 citation statements)

References 14 publications

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“…There were no differences between the trivalent and quadrivalent preparations with regard to safety and reactogenicity. [36][37][38][39][40][41] There is an increased cost associated with the use of quadrivalent vaccines but modeling studies suggest a significant societal cost saving even if the cost is significantly higher than the trivalent preparation. [42][43][44] …”

Section: Trivalent/ Quadrivalent Influenza Vaccinesmentioning

confidence: 99%

Evaluating the case for trivalent or quadrivalent influenza vaccines

Baxter

2016

Human Vaccines & Immunotherapeutics

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Influenza viruses circulate widely throughout the world and it is estimated that they affect between 5 and 15% of the population annually. Since 1977, four viruses co-circulate -two A Viruses (H1N1 and H3N2) and two B viruses (B Yamagata and B Victoria). Type A viruses generally cause up to two thirds of annual infections, although single country studies have shown that B infections may be the predominant virus in the one year in four.Influenza vaccines have traditionally included the hamagglutinins and neuraminidases from the two circulating A viruses and either B Yamagata or B Victoria -however, selecting the B strain for inclusion in these trivalent vaccines has variable success. The alternative approach is to include both B strains in a quadrivalent vaccine. Immunological studies of such vaccines show non-inferiority with a trivalent vaccine comparator, and significant superiority to the additional B strain.Quadrivalent vaccines are more expensive than trivalent preparations but theoretical evidence would suggest they are likely to be more effective and therefore play a much greater role in national immunisation programmes in the future.

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Section: Trivalent/ Quadrivalent Influenza Vaccinesmentioning

confidence: 99%

Evaluating the case for trivalent or quadrivalent influenza vaccines

Baxter

2016

Human Vaccines & Immunotherapeutics

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“…In the two randomized controlled phase II studies of Q-IIV4 in children aged 6-35 months, [69,70] the frequencies of both injection site and systemic AEs including fever, notable for its link with febrile seizures, following vaccination were comparable in the Q-IIV4 and IIV3 recipients, after dose 1 or 2, and across the age strata (6−17 months and 18 −35 months of age). [71] In all studies, [57,[67][68][69][70][71] regardless of age group, the rates of unsolicited AEs over 21 −28 days after vaccination and of medically attended and SAE during the entire clinical trials were comparable between Q-IIV4 and control groups. These outcomes provided assurance that Q-IIV4 posed no incremental safety risk relative to IIV3s.…”

Section: Reactogenicity and Safetymentioning

confidence: 85%

“…There have been two additional controlled trials of Q-IIV4 in children aged 6−35 months to support its eventual licensure in this group beyond Canada and Mexico. Overall, immunogenicity data are available for adults aged ≥18 years, [67,68] children aged 3-17 years, [69] and children aged 6-35 months [69][70][71] (Supplementary File 3).…”

Section: Q-iiv4mentioning

confidence: 99%

“…In a phase III study (NCT01196975; 2010-2011 [68]) conducted in adults in stable health aged ≥18 years (N = 1,703), Q-IIV4 had noninferior immunogenicity relative to Q-IIV3, formulated with either a B/Victoria or B/Yamagata strain, for the shared vaccine strains (per strain UL 95% CI for adjusted GMT [Q-IIV3/Q-IIV4] ≤1.5 and for SCR difference [Q-IIV3 minus Q-IIV4] ≤10%) and superior immunogenicity for the additional B lineage strain (LL 95% CI for adjusted GMT ratio [D-IIV4/D-IIV3] >1.5 and LL 95% CI SCR difference [Q-IIV4 minus Q-IIV3] >10%). Though immune responses were generally lower for subjects aged ≥65 years than those aged 18-65 years, the Q-IIV4 candidate was immunogenic for all four vaccine strains, and HI antibody responses against all strains fulfilled CBER immunogenicity acceptance criteria in both age strata (18-65 years and ≥65 years).…”

Section: Q-iiv4mentioning

confidence: 99%

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Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines

Bekkat-Berkani

Ray

Jain³

et al. 2015

Expert Review of Vaccines

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Inactivated trivalent influenza vaccines (IIV3s) are designed to protect against illness caused by two influenza A virus subtypes and one influenza B virus lineage. They may provide inadequate protection due to the co-circulation of viruses from two antigenically distinct influenza B lineages. Incorporating strains from both B lineages as in inactivated quadrivalent influenza vaccines (IIV4s) reduces this risk. We summarize the evidence supporting two IIV4s manufactured by GSK Vaccines. Compared to IIV3s, these two IIV4s demonstrated noninferior immunogenicity against the shared influenza strains and superior immunogenicity for the strain of the additional B lineage, particularly in subjects who were seronegative for that B strain. One IIV4's efficacy in children aged 3-8 years was 55.4% against influenza of any severity and 73.1% against moderateto-severe influenza. Both IIV4s were well-tolerated with a similar safety profile to IIV3s. These IIV4s are more likely than IIV3s to protect against the added influenza B strain. ARTICLE HISTORY

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“…As quadrivalent vaccines elicit antibody responses against viruses of both lineages (Domachowske et al, 2013;Kieninger et al, 2013;Langley et al, 2013;Tinoco et al, 2014), they eliminate the risk that the incorrect B lineage is selected for inclusion in the vaccine. However, unforeseen antigenic drift within either influenza B lineage may affect vaccine effectiveness, although not as dramatically as a lineage mismatch (Belshe et al, 2010).…”

Section: The Extent Of Cross-reactivity Of Influenza B Virus-specificmentioning

confidence: 99%

Influenza B virus-specific CD8+ T-lymphocytes strongly cross-react with viruses of the opposing influenza B lineage

Sandt

Dou

Trierum

et al. 2015

Journal of General Virology

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Influenza B viruses fall in two antigenically distinct lineages (B/Victoria/2/1987 and B/Yamagata/16/1988 lineage) that co-circulate with influenza A viruses of the H3N2 and H1N1 subtypes during seasonal epidemics. Infections with influenza B viruses contribute considerably to morbidity and mortality in the human population. Influenza B virus neutralizing antibodies, elicited by natural infections or vaccination, poorly cross-react with viruses of the opposing influenza B lineage. Therefore, there is an increased interest in identifying other correlates of protection which could aid the development of broadly protective vaccines. BLAST analysis revealed high sequence identity of all viral proteins. With two online epitope prediction algorithms, putative conserved epitopes relevant for study subjects used in the present study were predicted. The cross-reactivity of influenza B virus-specific polyclonal CD8 + cytotoxic T-lymphocyte (CTL) populations obtained from HLA-typed healthy study subjects, with intra-lineage drift variants and viruses of the opposing lineage, was determined by assessing their in vitro IFN-c response and lytic activity. Here, we show for the first time, to the best of our knowledge, that CTLs directed to viruses of the B/Victoria/2/1987 lineage cross-react with viruses of the B/Yamagata/16/1988 lineage and vice versa.

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Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III, randomized trial

Abstract: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.

Cited by 70 publications

References 14 publications

Evaluating the case for trivalent or quadrivalent influenza vaccines

Evaluating the case for trivalent or quadrivalent influenza vaccines

Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines

Influenza B virus-specific CD8+ T-lymphocytes strongly cross-react with viruses of the opposing influenza B lineage

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