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

Immunogenicity and safety of high-dose versus standard-dose quadrivalent inactivated influenza vaccine in patients living with HIV: a randomized controlled trial. (PubMed, Vaccine) - "To address this gap, we conducted a randomized, single-blinded, controlled trial to compare the immunogenicity and safety of the high-dose (HD) IIV4 (60 μg, Efluelda, Sanofi) with the SD IIV4 (15 μg, Vaxigrip Tetra, Sanofi)...In conclusion, HD IIV4 enhanced immunogenicity against the vaccine A/H3N2 strain compared with SD IIV4, without increasing the risk of adverse events compared to SD IIV4. These findings suggest that HD IIV4 may enhance immunogenicity in PLWH and warrant further investigation in studies evaluating clinical effectiveness (TCTR20230501002)."

Clinical • Journal • Human Immunodeficiency Virus • Infectious Disease • Influenza • Respiratory Diseases • CD4

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 | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Infectious Disease • Influenza • Renal Disease • Respiratory Diseases

24CH249: Impact of influenza vaccination on nasal resident memory immune responses and respiratory peripheral memory immune responses (clinicaltrialsregister.eu) - P4 | N=30 | Completed | Sponsor: Centre Hospitalier Universitaire De Saint Etienne

New P4 trial • Infectious Disease • Influenza • Respiratory Diseases

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