Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study

Treanor, John; Albano, Frank R.; Sawlwin, Daphne; Jones, Alison Graves; Airey, Jolanta; Formica, Neil; Matassa, Vince; Leong, Jane

doi:10.1016/j.vaccine.2017.02.066

Cited by 31 publications

(24 citation statements)

References 18 publications

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“…These results are consistent with previous large-scale studies of QIVs in adult populations. [9][10][11][12] In studies with age-stratification, the proportions of influenza B infection were estimated higher among young children compared to old adults during seasonal influenza epidemics.- 5,13 However, the influenza B epidemic also induced significant public health impacts on adults. In adults and adolescents, the proportion of influenza B reported variably according to geographical region and study period.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

Song

Jacob

Woo

et al. 2018

Human Vaccines & Immunotherapeutics

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Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV-GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/ unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

Song

Jacob

Woo

et al. 2018

Human Vaccines & Immunotherapeutics

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“…Some local injection site reactions were more common among those who received Afluria Quadrivalent, including an imbalance of Grade 3 injection site induration/swelling at 0.3% in the Afluria Quadrivalent group and 0.06% in the pooled Afluria trivalent groups), but rates of these reactions were low overall ( 77 , 78 ).…”

Section: Influenza Vaccine Composition and Available Productsmentioning

confidence: 97%

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season

et al. 2017

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Summary This report updates the 2016–17 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (MMWR Recomm Rep 2016;65[No. RR-5]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used. For the 2017–18 season, quadrivalent and trivalent influenza vaccines will be available. Inactivated influenza vaccines (IIVs) will be available in trivalent (IIV3) and quadrivalent (IIV4) formulations. Recombinant influenza vaccine (RIV) will be available in trivalent (RIV3) and quadrivalent (RIV4) formulations. Live attenuated influenza vaccine (LAIV4) is not recommended for use during the 2017–18 season due to concerns about its effectiveness against (H1N1)pdm09 viruses during the 2013–14 and 2015–16 seasons. Recommendations for different vaccine types and specific populations are discussed. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is available. Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 20, 2016; February 22, 2017; and June 21, 2017. New and updated information in this report includes the following: •Vaccine viruses included in the 2017–18 U.S. trivalent influenza vaccines will be an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain these three viruses and an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage). • Information on recent licensures and labelling changes is discussed, including licensure of Afluria Quadrivalent (IIV4; Seqirus, Parkville, Victoria, Australia); Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut); and expansion of the age indication for FluLaval Quadrivalent (IIV4; ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada), previously licensed for ≥3 years, to ≥6 months. • Pregnant women may receive any licensed, recommended, age-appropriate influenza vaccine. • Afluria (IIV3; Seqirus, Parkville, Victoria, Australia) may be used for persons aged ≥5 years, consistent with Food and Drug Administration–approved labeling. • FluMist Quadrivalent (LAIV4; MedImmune, Gaithersburg, Maryland) should not be used during the 2017–18 season due to concerns about its effectiveness against influenza A(H1N1)pdm09 viruses in the United States during the 2013–14 and 2015–16 influenza seasons. This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2017–18 season in the United States. A Background Document containing further information and a summary of these recommendations ar...

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“…In comparison, injection site reactions were also the most commonly reported adverse experience noted in Australian horses administered the equine influenza vaccine during the 2007 outbreak, but anecdotally reported at a significantly higher rate – up to 25% of vaccinated horses . Similarly in human medicine, injection site pain is the most common side effect of influenza vaccines and reported to occur in up to 52.9% of vaccine recipients …”

Section: Discussionmentioning

confidence: 99%

Virus‐neutralising antibody responses in horses following vaccination with Equivac® HeV: a field study

Tan

Hodge²,

Klein

et al. 2018

Aust Veterinary J

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Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority study

Abstract: Seqirus; Clinicaltrials.gov: NCT02214225.

Cited by 31 publications

References 18 publications

Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season

Virus‐neutralising antibody responses in horses following vaccination with Equivac® HeV: a field study

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