Fluzone High-Dose Quadrivalent (influenza vaccine) / Evotec, Sanofi - LARVOL DELTA

A Randomized Trial Demonstrates a 3-Shot Flu Vaccine Series Improves Protection over a Single Shot in Multiple Myeloma (ASH 2024) - "One quarter of all patients were receiving Daratumumab; 62% in the standard arm and 49% in the intense arm had never received Daratumumab. This randomized controlled trial demonstrates that myeloma patients significantly increased their seroprotection at the end of the season by receiving three Fluzone HD vaccinations at 0, 2, and 4 months compared to a single shot. Clinicians should consider this 3-dose vaccine series as the new standard in patients with multiple myeloma. Despite this 3-dose series, seroprotection for all strains was still just over 50% at week 21."

Clinical • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Oncology • Respiratory Diseases

Comparison of immunogenicity of adjuvanted and high dose influenza vaccination in long-term care facility residents. (PubMed, medRxiv) - P4 | "The current study compares adjuvanted trivalent inactivated flu vaccine (aTIV, FLUAD) versus high-dose flu vaccine (HD-IIV3, FLUZONE HD) to determine if they met non-inferiority standards for older long-term care facility (LTCF) residents...The recombinant influenza vaccine (RIV, Flublok) was assessed similarly in year two for a small number of participants who were carried over from year 1 (n=32)...For the primary outcome, aTIV is non-inferior to HD-IIV3 for HAI titer of H1N1 and H3N2 but failed to meet non-inferiority criteria for Influenza B and seroconversion for all assessed strains. For the secondary outcome, aTIV was non-inferior to HD-IIV3 for both titer and seroconversion of anti-neuraminidase for both H1N1 and H3N2."

Journal • Infectious Disease • Influenza • Respiratory Diseases

High Vs. Standard Dose Influenza Vaccine in Adult SOT Recipients (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases • Solid Organ Transplantation • Transplantation

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (clinicaltrials.gov) - P3 | N=7950 | Not yet recruiting | Sponsor: Novavax | Phase classification: P2/3 ➔ P3 | N=4000 ➔ 7950

Enrollment change • Phase classification • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

PSOT: High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients (clinicaltrials.gov) - P2 | N=312 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases • Solid Organ Transplantation • Transplantation

CO-ADMINISTRATION OF INTRANASAL M2SR (M2-DEFICIENT SINGLE REPLICATION) INFLUENZA VACCINE WITH FLUZONE HIGH DOSE INDUCES SUPERIOR IMMUNE RESPONSES TO FLUZONE HIGH DOSE IN OLDER ADULTS (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

Influenza vaccination with the Fluzone High Dose (HD) vaccine compared to the "standard" flu vaccine in Muhahad HMO (V-Congress 2024) - No abstract available

Infectious Disease • Influenza • Respiratory Diseases

Influenza vaccine for 2024-2025. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Systems Investigation of Vaccine Responses in Aging and Frailty (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Yale University

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • IL6

IGNITE P303: Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (clinicaltrials.gov) - P3 | N=8422 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=450000 | Not yet recruiting | Sponsor: Tor Biering-Sørensen

New P4 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65-85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial. (PubMed, Lancet Infect Dis) - P1b | "The H3N2 M2SR vaccine coadministered with Fluzone HD in older adults was well tolerated and provided enhanced immunogenicity compared with Fluzone HD administered alone, suggesting potential for improved efficacy of influenza vaccination in this age group. Additional studies are planned to assess efficacy."

Journal • P1 data • Infectious Disease • Influenza • Otorhinolaryngology • Pain • Respiratory Diseases

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial primary completion date: May 2024 ➔ May 2025

Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=1002 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age (clinicaltrials.gov) - P3 | N=1900 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=682 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=682 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=1002 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=560 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23 (clinicaltrials.gov) - P=N/A | N=1001 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | N=2041 ➔ 1001

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. (PubMed, Hum Vaccin Immunother) - "Of 133 AEFI (48 vaccinees) with time of onset reported, all occurred ≤7 days post-vaccination (RR 4.80%, 95% CI: 3.56, 6.31), which was similar to the 2021/22 season (RR 4.90%, 95% CI: 3.65, 6.43). The EPSS for HD-IIV4 and for SD-IIV4 in the 2022/23 influenza season did not suggest any clinically relevant changes in safety beyond what is known/expected for IIV4s."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Rush University Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer

A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age (clinicaltrials.gov) - P3 | N=1900 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders (clinicaltrials.gov) - P4 | N=165 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Infectious Disease • Influenza • Oncology • Plasmacytoma • Respiratory Diseases

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - P1 | N=233 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases • CRP