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- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Estimated Additional Burden Averted for the 2022-2023 influenza season from Use of Cell-Based Influenza Vaccines Compared to Egg-Based Influenza Vaccines Among People 0-64 Years of Age in the United States (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_3418;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Relative Effectiveness of Cell-Based Influenza Vaccines versus Egg-Based Influenza Vaccines: A Review of Test-Confirmed and Clinical Diagnosis-Based Outcomes (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_3037;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Impact of Low Influenza Immunization rates on U.S. Hospital System Resources. A Dynamic Model estimation. (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_2980;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Relative Vaccine Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines Against Test-Confirmed Influenza in the United States 2022-23 Influenza Season (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_2743;
- Comirnaty (tozinameran) / Pfizer, BioNTech, Kostaive (ARCT-154) / Arcturus Therap
Modelling the Relative Vaccine Effectiveness of ARCT-154 versus BNT162b2 in Younger and Older Adults (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1741;
- Comirnaty (tozinameran) / Pfizer, BioNTech, Kostaive (ARCT-154) / Arcturus Therap
Modelling the Relative Vaccine Effectiveness of ARCT-154 versus BNT162b2 using Immunogenicity Data (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1728;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
A Clinical and Economic Comparison of Non-Egg Influenza Vaccines in Adults 18-64 Years in the U.S. (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_1050;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The impact of influenza vaccines on hospitalization costs for older adults in the United States: A real-world economic assessment of adjuvanted trivalent influenza vaccine compared with quadrivalent standard influenza vaccine for the 2018-19 and 2019-20 influenza seasons () - Apr 9, 2024 - Abstract #AMCP2024AMCP_318;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The value of the influenza cell () - Apr 9, 2024 - Abstract #AMCP2024AMCP_317;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Cost-Effectiveness of the Influenza Cell-Based Vaccine in the U.S. Pediatric Population. A Dynamic Transmission Modelling Approach (Convention Center Exhibit Hall) - Mar 16, 2024 - Abstract #PAS2024PAS_3511;
As an opposite, within a high incidence season (HIS), switching from QIVe to QIVc may prevent 1.7 million symptomatic cases, 648,263 outpatient visits, 16,688 hospitalizations, and 2,126 deaths. In both scenarios, LIS and HIS, QIVc would be a cost-saving strategy with US$1.4B and US$468.7M savings from a societal perspective and US$989.8M and US$252.8M savings from a payer perspective, respectively.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Estimated Additional Burden Averted from Use of Cell-Based Influenza Vaccines Compared to Egg-Based Influenza Vaccines Among People 0-64 Years of Age in the United States: 2017-2020 Seasons (Convention Center Exhibit Hall) - Mar 16, 2024 - Abstract #PAS2024PAS_3509;
Across the 3 influenza seasons, use of IIV4c would result in prevention of an additional 12,706,837 symptomatic illnesses, 6,222,820 outpatient visits, 80,390 hospitalizations, and 2,765 deaths. DSA results showed that the rVE estimate was associated with the most variability while the burden estimates were most influential in the other two seasons.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Clinical and Economic Benefits of Adjuvanted and High-Dose Influenza Vaccines in the Elderly in Argentina () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_876;
In Argentina, the use of enhanced influenza vaccines in the elderly can increase vaccine effectiveness, reduce mortality and disease-related costs. Based on comparable vaccine effectiveness, significant economic advantages favor the MF59-adjuvanted inactivated influenza vaccine strategy due its expected lower acquisition costs.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
RSV Vaccine Development by Platform Technologies (Concourse C & D) - Nov 8, 2023 - Abstract #VaccinesRD2023Vaccines_RD_38;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Estimated Additional Burden Averted from Use of Cell-Based Influenza Vaccines Compared to Egg-Based Influenza Vaccines Among People 0-64 Years of Age in the United States: 2017-2020 Seasons (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_3180;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Phase I trial of two novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as 4th dose boosters (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_2578;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Incidence of Influenza-Related Medical Encounters Among Adults in The United States During the 2015-2020 Influenza Seasons (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_2066;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Incidence of Influenza-Related Medical Encounters Among Adults in The United States During the 2015-2020 Influenza Seasons (Poster Hall B+C - Arena 3) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_2060;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Value of the Influenza Cell-Based Vaccine in the Pediatric Population. A Dynamic Transmission Modelling Approach in the U.S. (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_2050;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Value of Influenza Vaccination in the Older Adult Population. A Stochastic Model Estimation of the benefit of vaccination to prevent the Severe Outcomes in the U.S. (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_1963;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Cost-Effectiveness Evidence of Enhanced Influenza Vaccines in Adults ?65 Years of Age: A Literature Review and Decision-Making Implications (Hall B + C) - Sep 6, 2023 - Abstract #IDWeek2023IDWeek_1962;
- Phase I trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster: interim analysis (C / 07) - Apr 2, 2023 - Abstract #ECCMID2023ECCMID_5767;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Bicistronic self-amplifying mRNA (sa-mRNA) vaccines targeting seasonal influenza A viruses are protective and immunogenic in a ferret model () - Mar 27, 2023 - Abstract #ISIRVFLU2023ISIRV_FLU_64;
Increased NA-mediated neutralization titers also coincided with reduced viral loads, further suggesting the added benefit of including the NA component in seasonal influenza vaccines. Given that the generation of mRNA vaccines are independent of in ovo systems, adaptive alterations of epitopes are avoided.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The Impact of the Influenza Immunization Rate Reduction on U.S. Hospital System Resources. An Influenza and COVID-19 Cocirculation Approach () - Mar 27, 2023 - Abstract #ISIRVFLU2023ISIRV_FLU_49;
Only increasing the flu immunization rate up to 70% or higher may prevent any saturation of acute hospital or ICU hospital beds. Conclusion Influenza vaccination remains a critical public health tool to improve health outcomes and avoid saturation of hospital system resources, especially those associated to ICU hospital beds within a co-circulation scenario.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Economic Impact of Influenza Vaccines on Hospitalization Costs for the US Elderly: A Real-World Economic Assessment of Adjuvanted Trivalent Influenza Vaccine Compared to Quadrivalent Standard-Dose Influenza Vaccine for the 2018-19 and 2019-20 Influenza Seasons () - Mar 27, 2023 - Abstract #ISIRVFLU2023ISIRV_FLU_47;
Likewise, the net cost savings associated with aIIV3 in the 2019- 20 season were $261.4 (180.5-341.6) and $114.5 (77.0-151.4) per recipient in terms of prevented cardio-respiratory and respiratory hospitalizations relative to IIV4e, respectively. Conclusion In the 2018-19 and 2019-20 influenza seasons, aIIV3 was associated with significant cost savings from avoided cardio-respiratory and respiratory hospitalizations costs compared to IIV4e.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
MF59-adjuvanted influenza vaccine for preventing cardio-respiratory hospitalizations in adults 65 years and older during the 2019-2020 U.S. influenza season () - Mar 27, 2023 - Abstract #ISIRVFLU2023ISIRV_FLU_40;
Consistent trends were observed when limiting to the primary/admitting diagnosis, except for ischemic stroke related hospitalizations for which no difference was observed compared to HD-TIV. Conclusion This real-world study demonstrated the benefit of aTIV over QIVe and HD-TIV for the prevention of cardio-respiratory related hospitalization outcomes during the 2019-20 season, including influenza-related hospitalizations.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The economic impact of the MF59 (D / 11) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4517;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
The cost-effectiveness of the MF59 (D / 11) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4516;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Cost-effectiveness of MF59 (C / 16) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4505;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Sponsored Session: Seqirus - Opioid Stewardship: From hospital to community () - Feb 3, 2023 - Abstract #APS2023APS_139;
Conclusion This real-world study demonstrated the benefit of aTIV over QIVe and HD-TIV for the prevention of cardio-respiratory related hospitalization outcomes during the 2019-20 season, including influenza-related hospitalizations. Sponsored by Seqirus
- IMMUNOGENICITY AND SAFETY OF DIFFERENT MF59-ADJUVANTED H5N1 (AH5N1) INFLUENZA VACCINE FORMULATIONS IN HEALTHY PEDIATRIC SUBJECTS (Auditorium VI+VII) - Jan 14, 2023 - Abstract #ESPID2023ESPID_73;
No clear effect of the H5N1 antigen dose on immune responses was observed with both MF59 dosages. These immunogenicity patterns were observed in the entire study population and in both age cohorts.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Aberrant Cellular Glycosylation Modifies the Influenza Glycome Without Genomic Changes Allowing Virus Evasion of Host Immune Responses (HALL 1A) - Sep 13, 2022 - Abstract #OPTIONSXI2022OPTIONS_XI_27;
HA and NA with reduced glycan occupancy generated lower total and protective antibody responses in mice than those with normal glycosylation. Conclusion Imbalanced cellular glycosylation can lead to sequence-neutral changes in the IV glycome, and these glycomemodified viruses may be less well recognized by the host innate and adaptive immune system resulting in a severe influenza and reduced IV vaccine efficacy.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring, Mosquirix (RTS,S) / GSK
The Future of Flu Protection: Novel Influenza Technologies (Room 8) - Jun 4, 2022 - Abstract #BIO2022BIO_105;
Panelists from multiple companies will discuss how these novel technologies address the unique aspects of the influenza virus, avoid the problem of egg adaptation, and will highlight the regulatory and market challenges for advancing new influenza products. Panelists will also discuss the interface between seasonal flu and pandemic flu and how these platforms may be used for rapid response to the next flu pandemic.
- |||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Trial completion, Trial completion date, Trial primary completion date: A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (clinicaltrials.gov) - Apr 25, 2022
P2, N=420, Completed, Sponsor: Seqirus
Panelists will also discuss the interface between seasonal flu and pandemic flu and how these platforms may be used for rapid response to the next flu pandemic. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Apr 2022 | Trial primary completion date: Dec 2022 --> Apr 2022
- ||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Clinical, P3 data, Preclinical, Journal: Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects. (Pubmed Central) - Apr 24, 2022
P3
aH5N1c influenza vaccine elicited high levels of antibodies following two vaccinations administered 21 days apart and met both CBER and former CHMP immunogenicity criteria at Day 43 among both younger and older adults with a clinically acceptable safety profile. Consistency of the three consecutive aH5N1c vaccine lots was demonstrated (NCT02839330).
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Seqirus Sponsored Session () - Feb 18, 2022 - Abstract #APS2022APS_157;
Consistency of the three consecutive aH5N1c vaccine lots was demonstrated (NCT02839330). Sponsored by Seqirus
- | Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Preclinical, Journal: Antibody responses against heterologous A/H5N1 strains for an MF59-adjuvanted cell culture-derived A/H5N1 (aH5N1c) influenza vaccine in healthy pediatric subjects. (Pubmed Central) - Jan 27, 2022
P2
Sponsored by Seqirus When given to children aged 6 months through 17 years, aH5N1c resulted in increased immunogenicity from baseline against all 5 heterologous A/H5N1 strains tested, demonstrating the potential of an MF59-adjuvanted, cell-derived A/H5N1 vaccine to provide cross-protection against other A/H5N1 strains (NCT01776554).
- ||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Clinical, P2/3 data, Journal: Analyses of Safety Profile and Homologous Antibody Responses to a Mammalian Cell-Based, MF59-Adjuvanted, A/H5N1, Pandemic Influenza Vaccine across Four Phase II/III Clinical Trials in Healthy Children, Adults, and Older Adults. (Pubmed Central) - Dec 29, 2021
P2, P3
Four studies (total N = 6230) assessed the immunogenicity and safety of mammalian cell-based, MF59-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ™) as two doses administered on Days 1 and 22 in children (NCT01776554), adults (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330)...MF59 allowed for antigen dose sparing. Solicited AEs were mild to moderate in nature, of short duration, and less frequent after the second dose than the first, demonstrating a favorable risk-benefit profile.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
[VIRTUAL] Relative vaccine effectiveness against influenza-related hospitalizations and respiratory events during the 2019/20 influenza season in U.S. children and adults. A Real-World Evidence comparison between quadrivalent cell-based and egg-based influenza vaccines () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_2236;
Solicited AEs were mild to moderate in nature, of short duration, and less frequent after the second dose than the first, demonstrating a favorable risk-benefit profile. QIVc was significantly more effective in preventing influenza-related and respiratory-related hospitalizations/ER visits, as well as all-cause hospitalizations, compared to QIVe-SD.
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
[VIRTUAL] Relative Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose Influenza Vaccine among U.S. Older Adults during 2019-20 Influenza Season () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_924;
QIVc was significantly more effective in preventing influenza-related and respiratory-related hospitalizations/ER visits, as well as all-cause hospitalizations, compared to QIVe-SD. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits, all-cause hospitalizations and hospitalizations/ER visits for CRD.
- ||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Enrollment change: A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (clinicaltrials.gov) - Aug 25, 2021
P2, N=420, Active, not recruiting, Sponsor: Seqirus
aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits, all-cause hospitalizations and hospitalizations/ER visits for CRD. N=96 --> 420
- ||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Enrollment change: A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (clinicaltrials.gov) - Aug 20, 2021
P2, N=96, Active, not recruiting, Sponsor: Seqirus
N=96 --> 420 N=420 --> 96
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
[VIRTUAL] Relative Vaccine Effectiveness Against Influenza-Related and Any Respiratory-Related Hospital Encounter During the 2019/20 High Influenza Activity Period: A Comprehensive Real-World Analysis to Compare Quadrivalent Cell-based and Egg-based Influenza Vaccines () - Aug 19, 2021 - Abstract #IDWeek2021IDWeek_705;
- Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
[VIRTUAL] Pandemics and Profit: Creating a sustainable business model (No, really!) () - May 31, 2021 - Abstract #BIO2021BIO_148;
This panel will examine the business of pandemics and how governments and other global stakeholders and industry can and must all balance their own economic needs and choices. The panelists will describe how we can evolve our approach to the business of pandemics for better future results
- ||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Enrollment closed: A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (clinicaltrials.gov) - Mar 18, 2021
P2, N=420, Active, not recruiting, Sponsor: Seqirus
The panelists will describe how we can evolve our approach to the business of pandemics for better future results Recruiting --> Active, not recruiting
- |||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Enrollment open, Trial completion date, Trial primary completion date: A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine (clinicaltrials.gov) - Dec 27, 2020
P2, N=420, Recruiting, Sponsor: Seqirus
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Trial completion date: Aug 2021 --> Dec 2022 | Trial primary completion date: Aug 2021 --> Dec 2022
- ||||||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Trial completion: A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ?18 Years of Age (clinicaltrials.gov) - Oct 19, 2017
P3, N=3196, Completed, Sponsor: Seqirus
Not yet recruiting --> Recruiting | Trial completion date: Aug 2021 --> Dec 2022 | Trial primary completion date: Aug 2021 --> Dec 2022 Active, not recruiting --> Completed
- |||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Trial primary completion date: A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ?18 Years of Age (clinicaltrials.gov) - Oct 26, 2016
P3, N=3192, Active, not recruiting, Sponsor: Seqirus
Active, not recruiting --> Completed Trial primary completion date: Jan 2017 --> Nov 2017
- ||||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Enrollment closed: A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ?18 Years of Age (clinicaltrials.gov) - Sep 7, 2016
P3, N=3192, Active, not recruiting, Sponsor: Seqirus
Trial primary completion date: Jan 2017 --> Nov 2017 Recruiting --> Active, not recruiting
- || Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
New P3 trial: A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ?18 Years of Age (clinicaltrials.gov) - Jul 20, 2016
P3, N=3192, Recruiting, Sponsor: Seqirus
- ||||||| Audenz (influenza A (H5N1) monovalent vaccine adjuvanted) / CSL Behring
Trial completion: Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine (clinicaltrials.gov) - May 14, 2015
P3, N=539, Completed, Sponsor: Novartis
Recruiting --> Active, not recruiting Active, not recruiting --> Completed