Flucelvax (influenza virus trivalent vaccine) / CSL Behring - LARVOL DELTA

RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - P4 | N=366 | Completed | Sponsor: Marshfield Clinic Research Foundation | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Myoglobin-Induced Acute Tubular Injury (KIDNEY WEEK 2025) - "One month prior, she had a routine visit to her Primary Care Physician (PCP), and received Seqirus Influenza Flucelvax 0.5ml after which she developed generalized myalgia for two weeks...Myoglobin is well known for its cytotoxic effects but as shown in this case, can persist in the renal tubules in the setting of normal CPK and urine myoglobin. We should always consider rhabdomyolysis in the differential and diagnostic workup of AKI with appropriate staining of renal biopsy samples."

Acute Kidney Injury • Anemia • Cardiovascular • Diabetes • Genetic Disorders • Hematological Disorders • Hypertension • Infectious Disease • Influenza • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Obesity • Renal Disease • Respiratory Diseases • Type 2 Diabetes Mellitus • MB

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

Absolute and Relative Effectiveness of Cell- and Egg-based Quadrivalent Inactivated Influenza Vaccine Products from 2014-2015 to 2018-2019 seasons, U.S. Flu VE Network. (PubMed, Clin Infect Dis) - "Comparisons of influenza vaccine products over multiple seasons showed benefit against symptomatic laboratory-confirmed outpatient influenza of both egg- and cell culture-based quadrivalent inactivated influenza vaccines, with similar absolute and relative levels of protection provided by each product."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Pharmacovigilance-based 12-year post-marketing safety analysis of quadrivalent influenza vaccines in children: a VAERS surveillance study. (PubMed, Front Pediatr) - "We conducted a comprehensive 12-year pharmacovigilance analysis utilizing data from the Vaccine Adverse Event Reporting System (VAERS) for individuals under 18 years receiving six FDA-approved QIVs between 2013 and 2024, representing three distinct platforms: four egg-based inactivated vaccines (Afluria, Fluarix, FluLaval, Fluzone), one cell culture-based inactivated vaccine (Flucelvax), and one live-attenuated intranasal vaccine (FluMist). This pharmacovigilance analysis demonstrates generally favorable safety profiles for pediatric QIVs, with cell culture formulations showing superior safety characteristics. The extremely low absolute risk of Guillain-Barré syndrome supports continued routine pediatric influenza vaccination while highlighting the importance of platform-specific safety monitoring."

Adverse events • Journal • P4 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=605 | Completed | Sponsor: Duke University | 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

Antibody responses to seasonal influenza vaccination (2023-24 Flucelvax) in individuals with obesity? (IMMUNOLOGY 2025) - "Moreover, OB group showed higher titers for A/Dar/6/2021 at all timepoints when compared to NOB group (baseline: p=0.015; Wk 1: p=0.003; Wk 4: p=0.009). These findings suggest that BMI may uniquely influence antibody response to influenza vaccination, underscoring the need for a larger study for a better understanding of vaccine immunogenicity in the obese population.Keywords: Animals Human; Cells B Cells; Infections Viral; Molecules Antibodies; Processes Memory"

Clinical • Late-breaking abstract • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Immune Responses to the 2023-24 Seasonal Influenza vaccination (Flucelvax) in individuals with obesity (IMMUNOLOGY 2025) - "There were no differences in the mean fold-rise and seroconversion rate between the OB and NOB. Overall, both OB and NOB groups had comparable antibody responses to seasonal influenza vaccine."

Clinical • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection (clinicaltrials.gov) - P=N/A | N=1500 | Active, not recruiting | Sponsor: University of Melbourne | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Jun 2025 | Trial primary completion date: Nov 2023 ➔ Jun 2025

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

First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults (clinicaltrials.gov) - P1 | N=63 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | N=35 ➔ 63

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=605 | Active, not recruiting | Sponsor: Duke University | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2025 ➔ Dec 2024

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

Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - P3 | N=366 | Completed | Sponsor: Tan Tock Seng Hospital | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=600 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=600 | Not yet recruiting | Sponsor: Duke University

New P4 trial • 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 primary completion date: May 2024 ➔ May 2025

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

Intramuscular CodaVax-H1N1 in Healthy Adults (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: Codagenix, Inc | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2023-2024. (PubMed, Can Commun Dis Rep) - "Key changes for the 2023-2024 season include: 1) incorporation of updated information/guidance on influenza vaccination in the context of the coronavirus disease 2019 (COVID-19); 2) new recommendations for Flucelvax® Quad and Influvac® Tetra, the two quadrivalent inactivated influenza vaccines with expanded paediatric age indications; and 3) an update to the format of the Statement. Overall, NACI continues to recommend that an age-appropriate influenza vaccine should be offered annually to all individuals aged six months and older who do not have a contraindication to the vaccine, with particular focus on the groups for whom influenza vaccination is particularly recommended."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Efficacy Study With QIVc in Pediatric Subjects (clinicaltrials.gov) - P3 | N=5723 | Completed | Sponsor: Seqirus | Active, not recruiting ➔ Completed | N=3830 ➔ 5723 | Trial primary completion date: Mar 2024 ➔ Nov 2023

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

First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine. (PubMed, Hum Vaccin Immunother) - "The objective of this paper is to summarize annual enhanced safety surveillance activity across three seasons (2019/20-2021/22) for cell culture-based quadrivalent influenza vaccine (QIVc; Flucelvax® Tetra) in all age groups...Within its limitations, results of this study support the favorable safety profile of QIVc. These safety data could further bolster public trust in influenza vaccines with the goal to increase vaccination uptake in all target groups."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Differential Induction of Interferon Stimulated Genes by Cell-based Versus Egg-based Quadrivalent Influenza Vaccines in Children During the 2018-19 Season. (PubMed, J Infect Dis) - "Peripheral blood mononuclear cells were isolated and RNA sequenced from 81 study participants (41 Fluzone, egg-based and 40 Flucelvax, cell based) pre- and 7 days post- vaccination. Participants who seroconverted had increased interferon signaling activation versus those who did not seroconvert. These data suggest that cell-based influenza vaccine stimulates immune activation differently from egg-based influenza vaccine, shedding light on reported differences in vaccine effectiveness."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial primary completion date: Aug 2023 ➔ Aug 2024

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • BCL2