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

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Rush University Medical Center | Trial completion date: Sep 2027 ➔ Dec 2027 | Trial primary completion date: Sep 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer

Brand-specific influenza vaccine effectiveness in three Nordic countries during the 2024-2025 season: a target trial emulation study based on registry data. (PubMed, Lancet Reg Health Eur) - "Brand-specific VE was 63.4% (38.1-88.7) for Efluelda Tetra (split virion-high dose), 48.2% (40.8-55.6) for Fluad Tetra (subunit standard-dose adjuvanted), 43.6% (23.7-63.6) for Vaxigrip Tetra (split virion standard-dose), and 30.6% (-7.8 to 69.1) for Influvac Tetra (subunit standard-dose)...Annual monitoring using Nordic registries is crucial for informing evidence-based vaccination strategies and regulatory decisions. European Medicines Agency."

Journal • Infectious Disease • Influenza • Respiratory Diseases

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...Conclusions : 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

Public Health Impact of Efluelda, a High-Dose Trivalent Influenza Vaccine (TIV-HD) Compared to Standard-Dose Trivalent Inactivated Vaccines (TIV-SD) (ISPOR-EU 2025) - "HD offers significant public health benefits over SD vaccines in adults aged 65-years and older. As hospitalizations mostly occur during the winter epidemic peak (8-10 weeks), HD may help ease seasonal hospital overcrowding and preserve healthcare capacity."

Infectious Disease • Influenza • Respiratory Diseases

Cost-Effectiveness and Budget Impact of High-Dose Trivalent Influenza Vaccine Efluelda® in Older Adults: A Greek Healthcare System Perspective (ISPOR-EU 2025) - "Efluelda® offers a cost-effective and potentially cost-saving intervention for influenza prevention in Greek adults aged 65 and older. Its adoption could substantially reduce the burden on the healthcare system, particularly by averting respiratory complications. These findings support the inclusion of Efluelda® in national vaccination strategies."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Influenza • Respiratory Diseases

Health-Related Quality of Life Following Administration of Influenza and COVID-19 Combination Vaccine in Older Adults: Results From a Phase 3 Randomized Controlled Trial (ISPOR-EU 2025) - P3 | "This study evaluated short-term HRQoL changes within the first 7 days post-vaccination in older adults (≥65 years), including subgroups aged 65-74 and ≥75 years, in a Phase 3, randomized, observer-blind, active-controlled trial (NCT06097273). Participants (1:1 randomization) received either mRNA-1083 with placebo or co-administered Fluzone High-Dose Quadrivalent (HD-IIV4) and mRNA-1273 (Spikevax). mRNA-1083 was associated with a transient and minor decrements in participants' HRQoL, which were not meaningful. These findings are consistent with other currently licensed vaccines and support the tolerability of mRNA-1083 from a patient-reported outcomes perspective."

Clinical • HEOR • P3 data • Herpes Zoster • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Varicella Zoster

Comparative analysis of cellular immune responses to four seasonal inactivated influenza vaccines in younger and older adults. (PubMed, J Immunol) - "Participants were categorized by age, 28-60 and 65-85 yr, and were vaccinated with 1 of 4 influenza vaccines (Fluzone Standard-Dose [FSD], Flucelvax [FCEL], Fluzone High-Dose [FHD], or Fluad [FAD]) during the 2023-2024 influenza season. These findings highlight the critical role of antigen dose and quality in inducing HA-specific cellular immunity and coordinating B and T cell activation. Synergistically engaging ASCs, cTfh, MBCs, and CD4+ T cells to enhance immunological memory and establish long-term vaccine-induced immunity should be considered in future influenza vaccine design."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4

High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater) (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Vanderbilt University Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Vanderbilt University Medical Center

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients (clinicaltrials.gov) - P2 | N=396 | Active, not recruiting | Sponsor: Vanderbilt University Medical Center | Trial primary completion date: Jul 2025 ➔ Jan 2026

Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Influenza vaccines for 2025-2026. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=466320 | Completed | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

DANFLU-2: A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults (clinicaltrials.gov) - P4 | N=332438 | Completed | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients (clinicaltrials.gov) - P=N/A | N=74 | Completed | Sponsor: University of Minnesota | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jun 2025

Trial completion • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=466320 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine (clinicaltrials.gov) - P3 | N=9320 | Active, not recruiting | Sponsor: Novavax | Trial completion date: Feb 2026 ➔ Sep 2026 | Trial primary completion date: May 2025 ➔ Jul 2026

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

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Rush University Medical Center | Trial completion date: Dec 2025 ➔ Sep 2027 | Trial primary completion date: Dec 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Breast Cancer • Infectious Disease • Influenza • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer

Development of an Influenza/COVID-19 Combination mRNA Vaccine Containing a Novel Multivalent Antigen Design That Enhances Immunogenicity of Influenza Virus B Hemagglutinins. (PubMed, Vaccines (Basel)) - "Our data demonstrate that the multimerization of antigens expressed as complex fusion proteins is a powerful antigen design approach that may be broadly applied toward mRNA vaccine development."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • 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=910 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • 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 completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

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

Tfh Dysfunction in HIV and Aging (clinicaltrials.gov) - P4 | N=400 | Recruiting | Sponsor: University of Miami | Trial completion date: Sep 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Influenza • Respiratory Diseases • CD4

A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=1162 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Which Enhanced Influenza Vaccine Has the Greatest Immunogenicity in Long-Term Care Residents: The Adjuvanted or the High-Dose Formulation? (PubMed, J Am Med Dir Assoc) - P4 | "Overall the antihemagglutinin and antineuraminidase titers demonstrate similarities between the vaccines and support them both being in the enhanced flu vaccine category preferentially recommended by the Centers for Disease Control and Prevention for people >65 years of age."

Journal • Infectious Disease • Influenza • Respiratory Diseases

DANFLU-2: A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults (clinicaltrials.gov) - P4 | N=339700 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 | Initiation date: Aug 2024 ➔ May 2025

Trial initiation date • Infectious Disease • Influenza • Respiratory Diseases