Fluzone high dose

Manufactured by Sanofi

Sourced in United States

Fluzone® High-Dose is a vaccine developed by Sanofi for the prevention of influenza in adults aged 65 years and older. It contains a higher dose of the influenza virus antigens compared to the standard-dose influenza vaccine.

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Lab products found in correlation

Fluquadri, by Sanofi (2 mentions) Fluzone quadrivalent, by Sanofi (1 mentions) Stata statistical software version 14, by StataCorp (1 mentions) Fluarix tetra, by GlaxoSmithKline (1 mentions)

10 protocols using fluzone high dose

Fluzone High-Dose Influenza Vaccine

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Fluzone® High-Dose (Sanofi Pasteur) is a trivalent inactivated vaccine that is administered intramuscularly. The vaccine contains influenza split virus antigens that are formulated to contain a total of 180 μg of influenza virus hemagglutinin (60 μg each from the three current influenza virus strains). During the 2014–2015 influenza season the vaccine contained: 1) an A/California/7/2009 (H1N1) pdm09-like virus; 2) A/Texas/50/2012 (H3N2)-like virus; 3) a B/Massachusetts/2/2012-like virus.

Branagan A.R., Duffy E., Albrecht R.A., Cooper D.L., Seropian S., Parker T.L., Gan G., Li F., Zelterman D., Boddupalli C.S., Zhang L., Verma R., Ferencz T.M, & Dhodapkar M.V. (2017). Clinical and serologic responses following a two dose series of high-dose influenza vaccine in plasma cell disorders: a prospective, single-arm trial. Clinical lymphoma, myeloma & leukemia, 17(5), 296-304.e2.

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Influenza Vaccine Responses in Older Adults

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During the 2014–2015 to 2019–2020 influenza seasons, we enrolled community-dwelling older adults above 75 years of age who had not yet received a seasonal influenza vaccine. Individuals who had a history of allergic reaction to influenza vaccines or to eggs, were currently taking oral steroids, or had worsening or new-onset of immune-modulating conditions (e.g., rheumatoid arthritis, hematologic malignancies, etc) were excluded. Study participants came to the Clinical Research Unit at Johns Hopkins Institute of Clinical and Translational Research on the Johns Hopkins Bayview Medical Center campus, or study visits were conducted at participants’ home as needed. A detailed medical history was obtained, vital signs were measured and frailty was assessed as per the Fried Frailty Phenotype⁴². After a pre-vaccination blood draw, participants received HD-IIV3 (Fluzone®High-Dose, Sanofi Pasteur, PA, USA). A second blood sample was collected between 21 and 28 days after vaccine administration (Fig. 1). To focus on the context of repeated annual vaccination, only individuals who participated in a minimum of 4 influenza seasons were included in this analysis.

Shapiro J.R., Li H., Morgan R., Chen Y., Kuo H., Ning X., Shea P., Wu C., Merport K., Saldanha R., Liu S., Abrams E., Chen Y., Kelly D.C., Sheridan-Malone E., Wang L., Zeger S.L., Klein S.L, & Leng S.X. (2021). Sex-specific effects of aging on humoral immune responses to repeated influenza vaccination in older adults. NPJ Vaccines, 6, 147.

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Influenza Vaccination in MBL and CLL Patients

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Persons with clinical HC MBL and previously untreated CLL who presented for routine outpatient clinical care through the specialized MBL/CLL clinic within the Mayo Clinic Hematology Division in Rochester, MN and who were already enrolled in the MBL/CLL natural cohort study, for which they provided informed consent, were recruited for participation in this study. Inclusion criteria were age ≥ 18 years, diagnosis of MBL or CLL that was not previously treated with chemotherapy or immunotherapy, and no prior receipt of the seasonal influenza vaccine during the influenza season when they entered the study. None of the participants received IVIG within 3 months before or after the study immunization. Vaccination occurred between October 14, 2013–November 8, 2013 and October 13, 2014–November 4, 2014. Participants received a single 0.5 mL dose of HD IIV3 (Fluzone^® High-Dose; Sanofi Pasteur) via intramuscular route in the deltoid muscle. Vaccines were stored according to package insert at 2–8 °C in temperature-monitored refrigerators. Cold chain was maintained until time of vaccine administration.

Whitaker J.A., Parikh S.A., Shanafelt T.D., Kay N.E., Kennedy R.B., Grill D.E., Goergen K.M., Call T.G., Kendarian S.S., Ding W, & Poland G.A. (2021). The humoral immune response to high-dose influenza vaccine in persons with monoclonal B-cell lymphocytosis (MBL) and chronic lymphocytic leukemia (CLL). Vaccine, 39(7), 1122-1130.

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Fluzone High-Dose Vaccine Administration

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Following approximately 10 weeks of treatment, blood was drawn and then Fluzone high dose inactivated trivalent flu vaccine (Fluzone High-dose, Sanofi Pasteur Inc., Swiftwater, PA) was administered intramuscularly to each subject.

Martin D.E., Cadar A.N., Panier H., Torrance B.L., Kuchel G.A, & Bartley J.M. (2023). The effect of metformin on influenza vaccine responses in nondiabetic older adults: a pilot trial. Immunity & Ageing : I & A, 20, 18.

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Comparison of 2018 Southern Hemisphere IIV

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All participants received the 2018 southern hemisphere IIV appropriate for their age group and provided by their workplace or residence. Participants aged 18–50 years received standard dose QIV containing 15 μg of each HA (Afluria®Quad, Seqirus, Australia, or FluQuadri™, Sanofi, France). Participants aged ≥65 years received either Fluzone® High‐Dose (Sanofi) TIV containing 60 μg of each HA, or FLUAD® (Seqirus) adjuvanted TIV with 15 μg of each HA and formulated with MF59C.1. The vaccine compositions included A/Michigan/45/2015 (H1N1)pdm09‐like, A/Singapore/INFIMH‐16‐0019/2016 (H3N2)‐like and B/Phuket/3073/2013‐like viruses for TIV, and B/Brisbane/60/2008‐like virus included for QIV.

Mordant F.L., Price O.H., Rudraraju R., Slavin M.A., Marshall C., Worth L.J., Peck H., Barr I.G., Sullivan S.G, & Subbarao K. (2022). Antibody titres elicited by the 2018 seasonal inactivated influenza vaccine decline by 3 months post‐vaccination but persist for at least 6 months. Influenza and Other Respiratory Viruses, 17(1), e13072.

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RSV Prefusion Antigen Vaccine Formulations

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RSVpreF formulations contained equal amounts of 2 stabilized prefusion F antigens, 1 from the subgroup A/Ontario strain and 1 from the subgroup B/Buenos Aires strain, totaling 60 μg, 120 μg, or 240 μg, with or without 0.2 mg Al(OH)₃. Commercially available quadrivalent SIIV (Fluzone Quadrivalent, Sanofi Pasteur, Swiftwater, Pennsylvania) was administered to participants 18–49 years of age, and high-dose trivalent SIIV (Fluzone High-Dose, Sanofi Pasteur) was administered to participants 65–85 years of age [22 , 23 ]. For the 2018–2019 influenza season, high-dose trivalent SIIV contained strains A/Michigan/45/2015 (H1N1)pdm09-like, A/Singapore/INFIMH-16-0019/2016 A(H3N2)-like, and B/Colorado/06/2017-like (Victoria lineage), and the quadrivalent SIIV additionally contained a B/Phuket/3073/2013-like (Yamagata lineage) strain. Placebo was a sterile 0.9% sodium chloride solution.

Falsey A.R., Walsh E.E., Scott D.A., Gurtman A., Zareba A., Jansen K.U., Gruber W.C., Dormitzer P.R., Swanson K.A., Jiang Q., Gomme E., Cooper D, & Schmoele-Thoma B. (2021). Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. The Journal of Infectious Diseases, 225(12), 2056-2066.

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Influenza Vaccine Response in Older Adults

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Older adults were recruited from the Johns Hopkins Longitudinal Influenza Immunization Study of Aging over 75 years of age (JH LIISA 75+) cohort during the 2019–20, 2020–21, 2021–22, and/or 2022–2023 influenza seasons (25 (link)). Individuals who had a history of allergic reaction to influenza vaccines or to eggs, were currently taking oral steroids, or had worsening or new-onset of immune-modulating conditions (e.g., rheumatoid arthritis, hematologic malignancies, etc) were excluded. Sex and age were measured by self-report. After a pre-vaccination blood draw, participants received the high-dose inactivated influenza vaccine (Fluzone^®High-Dose, Sanofi Pasteur, PA, USA).

Shapiro J.R., Seddu K., Park H.S., Lee J.S., Creisher P.S., Yin A., Shea P., Kuo H., Li H., Abrams E., Leng S.X., Morgan R, & Klein S.L. (2023). The intersection of biological sex and gender in adverse events following seasonal influenza vaccination in older adults. Research Square.

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Formulation of Influenza Vaccine for MIMIX

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Trivalent influenza vaccine (Fluzone® High-Dose, Sanofi Pasteur) was obtained from Henry-Schein Medical. For 2017-18 vaccine, influenza antigens included A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), and B/Brisbane/60/2008 (B Victoria lineage). For 2018-19 vaccine, influenza antigens included A/Michigan/45/2015 (H1N1), A/Singapore/INFIMH-16-0019/2016 (H3N2), and B/Maryland/15/2016 (B/Colorado/6/2017-like virus, B Victoria lineage). All vaccines include <100 μg formaldehyde (inactivating agent) and < 250 μg octylphenol ethoxylate (Triton X-100, splitting agent) per dose. Detergent was removed from vaccine prior to formulation into MIMIX using purification columns (Pierce Detergent Removal Spin Column, ThermoFisher 87778). Removal of detergent was confirmed to have no impact on immunogenicity of the vaccine (Figure S3).

Stinson J.A., Boopathy A.V., Cieslewicz B.M., Zhang Y., Hartman N.W., Miller D.P., Dirckx M., Hurst B.L., Tarbet E.B., Kluge J.A, & Kosuda K.M. (2021). Enhancing influenza vaccine immunogenicity and efficacy through infection mimicry using silk microneedles. Vaccine, 39(38), 5410-5421.

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High-Dose Influenza Vaccine Study in Older Adults

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Older adults were recruited from the Johns Hopkins Longitudinal Influenza Immunization Study of Aging over 75 years of age (JH LIISA 75+) cohort during the 2019-20, 2020-21, 2021-22, and/or 2022–2023 influenza seasons [29 (link)]. Individuals who had a history of allergic reaction to influenza vaccines or to eggs, were currently taking oral steroids, or had worsening or new-onset of immune-modulating conditions (e.g., rheumatoid arthritis, hematologic malignancies, etc.) were excluded. Sex and age were measured by self-report. After a pre-vaccination blood draw, participants received the high-dose inactivated influenza vaccine (Fluzone®High-Dose, Sanofi Pasteur, PA, USA).

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Adverse Events Comparison of Influenza Vaccines

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Rates of adverse events were summarized by brand and type for HD-IIV3 (Fluzone High-Dose [Sanofi-Aventis]), aIIV3 (FLUAD [Seqirus]), and all standard nonadjuvanted QIIV brands in use (ie, Fluarix Tetra [GlaxoSmithKline], FluQuadri [Sanofi-Aventis], Afluria Quad [Seqirus], and Influvac Tetra [Mylan Health]) (Table 1), although these were not preferentially recommended in the study age group. Rates were compared using Pearson χ² test. Characteristics of respondents who received HD-IIV3 and aIIV3 alone or with a concomitant vaccine were compared using Pearson χ² test. P values were 2-sided, and statistical significance was set at P < .05.
Univariate analysis identified variables (chosen a priori) associated with adverse events and medical attention. Variables were included in a multivariable general linear model with Poisson distribution if they had a P < .25. Variables were retained in the multivariable model if they had a P < .05. All analysis was conducted in Stata statistical software version 14.2 (StataCorp). Analyses were conducted from September 1, 2018, to June 30, 2019.

Pillsbury A.J., Fathima P., Quinn H.E., Cashman P., Blyth C.C., Leeb A, & Macartney K.K. (2020). Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older. JAMA Network Open, 3(5), e204079.

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