VaxiGrip QIV IM (quadrivalent inactivated influenza vaccine) / Sanofi - LARVOL DELTA

Influenza vaccines promote humoral and cellular immune responses: a randomized, double-blind, phase 3 trial. (PubMed, Nat Commun) - P3 | "Here, we report findings from a randomized, double-blind, active-controlled phase 3 clinical trial (NCT05431725) that includes 334 healthy adults aged 18-64 years and evaluates the humoral and cellular antiviral immune responses induced by two inactivated QIVs, Sinovac-QIV and Vaxigrip-Tetra™. Cellular immune responses using ELISPOT and supervised and unsupervised flow cytometry analyses show that both vaccines modulate the frequency of hemagglutinin-specific CD4+ and CD8+ T cell subsets, inducing distinct T cell response profiles. Although cellular analyses are evaluated in a subgroup of the cohort, the data indicate that both QIVs induce robust humoral and cellular immunity in adults, providing mechanistic insights into vaccine-induced protection."

Clinical • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

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 Novel Carbohydrate Fatty-Acid Monosulphate Ester, Squalane-in-Water Adjuvant Is Safe and Enhances Inactivated Influenza Vaccine Immunogenicity in Older Adults. (PubMed, Vaccines (Basel)) - "In this phase 1b, double-blind, active-controlled clinical trial, 36 YAs (18-50 years) and 48 OAs (≥60 years) were randomized (1:1:1) to receive either 0.5 mg or 1 mg LVA combined with VaxigripTetra, or VaxigripTetra alone...The 1 mg dose of LVA was more immunogenic, highlighting its potential utility in this target population. Future research will focus on elucidating the mechanisms underlying the immunostimulatory effect of the CMS-based adjuvant."

Clinical • Journal • Infectious Disease • Influenza • Pain • Respiratory Diseases

CHRONOVAX 2: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure (clinicaltrials.gov) - P=N/A | N=735 | Recruiting | Sponsor: Centre Hospitalier Universitaire de Nice | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Infectious Disease • Influenza • Renal Disease • Respiratory Diseases

Epitope Variation in Hemagglutinin and Antibody Responses to Successive A/Victoria A(H1N1) Strains in Young and Older Adults Following Seasonal Influenza Vaccination: A Pilot Study. (PubMed, Vaccines (Basel)) - "Antibody responses were measured pre- and 28 days post-Vaxigrip Tetra vaccination in young (18-35) and older (>65) adults, stratified by cytomegalovirus (CMV) serostatus...Age groups differed: older adults showed greater variability, while younger CMV+ individuals tended toward stronger 2019 HA responses. These findings suggest a complex interplay of factors shaping immune responses, though the imprinting effect and the potential role of CMV warrant further exploration in larger, more focused studies."

Journal • Cytomegalovirus Infection • Infectious Disease • Influenza • Respiratory Diseases

INVITED: INfluenza VaccInation To Mitigate typE 1 Diabetes (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Aarhus University Hospital | Trial completion date: Jun 2026 ➔ May 2027 | Trial primary completion date: Apr 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Diabetes • Infectious Disease • Influenza • Metabolic Disorders • Respiratory Diseases • Type 1 Diabetes Mellitus

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

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2 (clinicaltrials.gov) - P=N/A | N=735 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire de Nice

New trial • Chronic Kidney Disease • Infectious Disease • Influenza • Renal 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

Safety and Efficacy of Influenza Vaccination in Kidney Graft Recipients in Late Period After Kidney Transplantation. (PubMed, Vaccines (Basel)) - "Influenza vaccination prevents severe infections in KTx recipients, with good serological response and no impact on graft function or severe adverse events."

Journal • Infectious Disease • Influenza • Pain • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Population Aged 3 Years and Older in Chile and the Philippines: A Phase 3, Non-Inferiority, Double-Blind, Randomized Controlled Clinical Trial. (PubMed, Vaccines (Basel)) - "The immunogenicity of Sinovac QIV was non-inferior to that of the comparator QIV in these populations aged 3 years and older, and safety was comparable."

Clinical • Head-to-Head • Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

TETRALITE-Ib: Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine (clinicaltrials.gov) - P1/2 | N=84 | Active, not recruiting | Sponsor: LiteVax BV | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases • CD8 • CRP • IFNG • IL2 • TNFA

Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent (clinicaltrials.gov) - P3 | N=2202 | Completed | Sponsor: Sinovac Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Cell-Mediated Proteomics, and Serological and Mucosal Humoral Immune Responses after Seasonal Influenza Immunization: Characterization of Serological Responders and Non-Responders. (PubMed, Vaccines (Basel)) - "Peripheral blood mononuclear cells were stimulated with trivalent influenza vaccine VaxiGripTetra, and supernatants were analysed for influenza-specific responses with the Olink Immune-Oncology panel using a proximity extension assay...In conclusion, our results did not show any correlation between serological response and age. Furthermore, the majority of influenza-specific cell-mediated immune markers did not differ between responders and non-responders; the immune marker profile of the non-responders and its contribution to protection is of interest but needs to be further explored."

Journal • Infectious Disease • Influenza • Oncology • Respiratory Diseases • CXCL13 • CXCL3 • GZMB • IFNG • IL10 • IL12A

The early safety profile of simultaneous vaccination against influenza and Respiratory Syncytial Virus (RSV) in patients with high-risk heart failure. (PubMed, Vaccine) - "In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September 15th to November 17th, 2023. Notably, there were no exacerbations of HF, hospitalizations, or deaths within a week post-vaccination. This study indicates the safety of simultaneous influenza and RSV vaccination in high-risk HF patients, with a low incidence of mild adverse events."

Journal • Cardiovascular • Congestive Heart Failure • Fatigue • Heart Failure • Infectious Disease • Influenza • Musculoskeletal Pain • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

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

TETRALITE-Ib: Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: LiteVax BV

New P1/2 trial • Infectious Disease • Influenza • Respiratory Diseases • CD8 • CRP • IFNG • IL2 • TNFA

Immunogenicity and safety of a quadrivalent recombinant influenza vaccine manufactured in Iran (FluGuard) in volunteers aged 18-60 years: A double-blind, non-inferiority, randomized controlled trial. (PubMed, Vaccine) - "Our findings support the non-inferiority of the FluGuard vaccine to the Vaxigrip vaccine regarding immunogenicity and safety."

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

FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - P3 | N=206 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24 (clinicaltrials.gov) - P=N/A | N=2075 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24 (clinicaltrials.gov) - P=N/A | N=2000 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Influenza Vaccine Type-Dependent Antibody Response in Patients with Autoimmune Inflammatory Rheumatic Diseases. (PubMed, Eur J Rheumatol) - "Influenza antibody levels following vaccination with Influvac in bDMARD-treated patients with AIIRDs were superior to Vaxigrip and VaxigripTetra. Treatment with methotrexate (MTX) did not reduce the antibody response."

Journal • Ankylosing Spondylitis • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Psoriatic Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI) (clinicaltrials.gov) - P=N/A | N=20 | Active, not recruiting | Sponsor: University Medicine Greifswald | Trial completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - P3 | N=206 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial primary completion date: Oct 2023 ➔ Apr 2023

Trial primary completion date • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases