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

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 | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. (PubMed, Hum Vaccin Immunother) - "No safety signal was detected during this surveillance. The 2023-24 season surveillance did not suggest any clinically significant changes in safety profile compared with previously reported safety data for SD-IIV4 and HD-IIV4."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. (clinicaltrials.gov) - P=N/A | N=670 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2028 ➔ Dec 2030

Enrollment open • Trial initiation date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Novavax | N=1925 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Influenza • Novel Coronavirus Disease • 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 | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2024 ➔ Jul 2025

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

Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial. (PubMed, EClinicalMedicine) - P3 | "Participants aged ≥65-years were randomised to the Coad_SD or Control_SD groups, or to Coad_HD or Control_HD groups that received a seasonal quadrivalent HD (high-dose) influenza vaccine (Fluzone High-Dose Quadrivalent, Sanofi Pasteur Inc) in the same schedules. Co-administration of seasonal influenza vaccine with Ad26.COV2.S was immunogenic with an acceptable safety profile, supporting co-administration of these vaccines. Janssen Vaccines & Prevention BV and Biomedical Advanced Research and Development Authority."

Head-to-Head • Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

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=1158 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • 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

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine (clinicaltrials.gov) - P2/3 | N=1925 | Not yet recruiting | Sponsor: Novavax | Trial completion date: May 2025 ➔ May 2026 | Initiation date: Nov 2024 ➔ Feb 2025 | Trial primary completion date: Nov 2024 ➔ Nov 2025

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

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=1158 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • 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 | Not yet recruiting | Sponsor: Novavax | Trial completion date: Apr 2025 ➔ Feb 2026

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

Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. (clinicaltrials.gov) - P=N/A | N=670 | Not yet recruiting | Sponsor: Sanofi

New trial • Infectious Disease • Influenza • Respiratory Diseases

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX (clinicaltrials.gov) - P=N/A | N=38 | Completed | Sponsor: Centre Hospitalier Universitaire de Nice | Recruiting ➔ Completed | N=100 ➔ 38 | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2024 ➔ Jun 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • Transplantation

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