Fluzone (influenza vaccine) / Sanofi - LARVOL DELTA

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=172 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | N=325 ➔ 172

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Infectious Disease • Influenza • Non-melanoma Skin Cancer • Oncology • Respiratory Diseases • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

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

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

Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations (clinicaltrials.gov) - P4 | N=23 | Completed | Sponsor: La Jolla Institute for Immunology | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Elevated NK and T cell-associated cytokines in plasma are associated with serological response to influenza vaccination. (PubMed, Front Immunol) - "A cohort of 100 people were sampled pre- (Day 0) and post-vaccination (Day 7) with the inactivated, quadrivalent Fluzone construct in the autumn of 2019 (UGA4)...In conclusion, plasma chemokines and cytokine levels prior to or in the first few days post-influenza vaccination may be predictive of serological responses to vaccination, with changes in IFN-γ, IL-17A, and IL-15 post-vaccination possibly indicative of the activation of cell-mediated immunity. These findings support the need for larger, high-resolution studies exploring the role of plasma proteomics in serological responses to influenza vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CCL11 • CCL2 • CCL22 • IFNG • IL15 • IL17A

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

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

Influenza strain-specific T cell responses longitudinally post-vaccination with FluZone. (PubMed, Vaccine) - "Dynamics of cytokine-producing T cells early post-influenza vaccination may reflect ongoing immune responses, but activated and degranulating T cells better represent longitudinal changes in serological responses. Differences between T cells specific to influenza A and B subtypes warrant further investigation to understand why they diverge and the relevance to vaccine design and evaluation."

Journal • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases • IFNG

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=605 | Completed | Sponsor: Duke University | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2019 ➔ Aug 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

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

Impact of age and prior COVID-19 on the response to influenza a components in the 2020-2021 Fluzone vaccine. (PubMed, Vaccine) - "While prior COVID-19 infection was not associated with notable differences in the humoral response in this cohort, older age consistently correlated with reduced responses across multiple readouts. These findings highlight the need for targeted approaches to improve influenza vaccine effectiveness in older adults, who remain at elevated risk for severe outcomes from both influenza virus and SARS-CoV-2 infections."

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

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

A phase I study of the safety, reactogenicity and immunogenicity of two quadrivalent seasonal influenza vaccines (Fluzone® or Flublok®) with or without one of two adjuvants (AF03 or Advax-CpG55.2) in healthy adults 18-45 years of age. (PubMed, Vaccine) - P1 | "In this highly immunologically-experienced cohort, neither AF03 nor Advax-CpG55.2 demonstrated notable benefit when added to the seasonal influenza vaccine. (ClinicalTrials.gov ID# NCT03945825)."

Clinical • Journal • P1 data • Infectious Disease • Influenza • Respiratory Diseases

High dose inactivated influenza vaccine inconsistently improves heterologous antibody responses in an elderly human cohort. (PubMed, J Infect Dis) - "We suggest that further increases in dose might be worth investigating to help induce a stronger broad response."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Estimating standard-dose and high-dose Fluzone vaccine efficacies for influenza A based on HAI titers. (PubMed, J Infect Dis) - "While HD Fluzone vaccines lead to a small increase in estimated VE compared to SD in older adults, further increases in dose or other developments to improve VE should be considered."

Journal • 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

B-cell dynamics underlying poor response upon split-inactivated influenza virus vaccination. (PubMed, Front Immunol) - "This investigation elucidated the differences in humoral and H1N1 HA-specific memory B-cells response in participants exhibiting distinct immune response patterns prior to and after vaccination with Fluzone, the quadrivalent split-inactivated seasonal influenza virus vaccine...Conversely, persistent responders had a positive correlation between HAI titers and IgA resting memory B-cells and a negative correlation between IgG memory B-cells and DN memory B-cells. Overall, this study provided valuable insights into the differential immune memory B-cell responses following influenza virus vaccination and paves the way for future research to further unravel the complexities of vaccine-induced memory B-cells and ultimately improve vaccination strategies against influenza virus infection."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD21

Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children (clinicaltrials.gov) - P4 | N=3425 | Completed | Sponsor: McMaster University | Unknown status ➔ Completed | N=2500 ➔ 3425

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=98 ➔ 325

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases