Influvac (influenza virus surface antigens) / Abbott, Viatris - LARVOL DELTA

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine As a Booster on Participants Previously Administered with OVX836 (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Osivax | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Jun 2025

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

Human Milk Oligosaccharides in Combination with Galacto- and Long-Chain Fructo-Oligosaccharides Enhance Vaccination Efficacy in a Murine Influenza Vaccination Model. (PubMed, Nutrients) - "Influvac-specific IgG1 and IgG2a levels were assessed using ELISAs, while splenic T and B lymphocytes were analyzed for frequency and activation via flow cytometry...GFH-fed mice also exhibited more activated splenic Th1 cells (CD69+ CXCR3+ CD4+) and higher IFN-γ production after ex vivo restimulation (p < 0.05). These findings suggest that GOS/lcFOS and HMOS, particularly in combination, enhance vaccine responses by improving memory B cells, IgG production, and Th1 cell activation, supporting the potential use of these prebiotics in infant formula for better early-life immune development."

Combination therapy • Journal • Preclinical • Immunology • Infectious Disease • Influenza • Respiratory Diseases • CD27 • CD4 • CD69 • CXCR3 • IFNG

Maternal cigarette smoke exposure in mice induces a Th2-biased immune response in offspring (ERS 2024) - "Two weeks after weaning, the offspring were either challenged with HDM or were injected with Influvac vaccine...In conclusion, early life exposure to CS can affect immune development in offspring. The offspring showed a bias towards Th2 immunity resulting in an exacerbated allergic immune response to allergens."

Preclinical • Immunology

Immunogenicity and Safety of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836 (clinicaltrials.gov) - P2 | N=214 | Not yet recruiting | Sponsor: Osivax

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Is the immune response to influenza vaccination in obese children the same as in normal weight children (clinicaltrialsregister.eu) - P4 | N=60 | Sponsor: Landspitali University hospital

New P4 trial • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Parc Taulí Hospital Universitari

New trial • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • IFNG • IL10 • IL1B • IL6

Maternal Cigarette Smoke Exposure in mice induces a Th2-biased immune response in Offspring (ERS LSC 2024) - "Two weeks after weaning, the offspring were either intranasally challenged with house dust mite extract (HDM) to measure lung function, T cell subsets in the lungs, bronchoalveolar lavage fluid (BALF) cell counts, and antigen-specific serum immunoglobulins (IgE and IgG1) or were twice injected with Influvac vaccine to assess delayed-type hypersensitivity (DTH) response, serum IgG1 and IgG2a, and splenic T cells...In conclusion, early life exposure to CS can affect immune development in offspring. The offspring showed a bias towards Th2 immunity resulting in an exacerbated allergic immune response to allergens."

Preclinical • Allergy • Immunology • Inflammation

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

Influvac Tetra: clinical experience on safety, efficacy, and immunogenicity. (PubMed, Expert Rev Vaccines) - "ECDC recommends that EU Member States implement action plans and policies aimed at reaching 75% coverage in at-risk groups and healthcare workers. Even so, vaccine coverage is still far from recommended."

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

Immune Responses after One Versus Two Influenza A/B Vaccinations in Patients with Multiple Myeloma (ASH 2023) - "Data from the pre-lenalidomide era highlighted poor vaccination responses, with sufficient seroconversion in 39% of patients with MM after single vaccination and an increase to 55% after additional boosting... In this retrospective single-center study, we analyzed the serological response from 71 patients with MM treated at our institution who received the annual Influenza A/B vaccination (Influvac Tetra, Mylan, Troisdorf, Germany) in the 2019/20 season... Together, 63.3% of patients with MM achieved a sufficient serological response after tetravalent Influenza A/B vaccination without a significant general benefit for a prime and boost approach. Current therapy, uncontrolled MM, present immunoparesis and low CD19+ B-cell counts were associated with inferior response rates. Those patients exceptionally benefitting from a boost vaccination were characterized by recent autoHSCT."

Clinical • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Oncology • Respiratory Diseases • Transplantation • CD4

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

Phase I clinical study to evaluate the safety and tolerability of Quadrivalent Influenza Vaccine (QIV) delivered intradermally by a high-density micro-array patch (HD MAP), compared to intramuscular Influvac® Tetra injection, in healthy adults aged 18 to 50 years (ANZCTR) - P=N/A | N=150 | Completed | Sponsor: Vaxxas Pty Ltd | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and Reactogenicity of Coadministration of COVID-19 and Influenza Vaccines. (PubMed, JAMA Netw Open) - "This prospective cohort study included health care workers at a large tertiary medical center in Israel who received the Influvac Tetra (Abbott) influenza vaccine (2022/2023), the Omicron BA.4/BA.5-adapted bivalent (Pfizer/BioNTech) vaccine, or both. Geometric mean titers in the coadministration group were estimated to be 0.84 (95% CI, 0.69-1.04) times lower than in the COVID-19 vaccine-alone group. In this cohort study of health care workers who received a COVID-19 vaccine, an influenza vaccine, or both, coadministration was not associated with substantially inferior immune response or to more frequent adverse events compared with COVID-19 vaccine administration alone, supporting the coadministration of these vaccines."

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

Results from the Enhanced Passive Safety Surveillance for the influenza vaccine Influvac® Tetra in Germany and Italy during 2022/2023 vaccination season (ESWI 2023) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

Phase I clinical study to evaluate the safety and tolerability of Quadrivalent Influenza Vaccine (QIV) delivered intradermally by a high-density micro-array patch (HD MAP), compared to intramuscular Influvac® Tetra injection, in healthy adults aged 18 to 50 years (ANZCTR) - P=N/A | N=150 | Recruiting | Sponsor: Vaxxas Pty Ltd | Initiation date: Nov 2000 ➔ Nov 2022

Trial initiation date • Infectious Disease • Influenza • Respiratory Diseases

Subsequent vaccinations in VITT patients other than SARS-CoV2 vaccination (#43) (GTH 2023) - "Introduction Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare, but severe side effect after vaccination with adenovirus vector-based vaccines (ChAdOx1 nCoV-19, AstraZeneca and Ad26.COV2.S, Johnson & Johnson/Janssen) in which platelet activating anti-platelet factor 4 (PF4) antibodies cause thrombocytopenia and thrombosis at unusual sites...During the follow-up period, eight vaccinations other than against Covid-19 were reported: six vaccinations against influenza (three Influvac, two Vaxigrip Tetra, one Influsplit Tetra) and two consecutive vaccinations against tick-borne encephalitis (TBE) in one patient...Conclusion Similar to observations after consecutive mRNA vaccinations against Covid-19 in VITT patients, vaccinations against influenza and TBE very unlikely to reactivate platelet-activating anti-PF4-antibodies. Further follow up of the VITT patient cohort is performed to detect any new safety signal related to recurrence of VITT."

Clinical • Cardiovascular • CNS Disorders • Hematological Disorders • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Thrombocytopenia • Thrombosis

Effectiveness of influenza vaccination against SARS-CoV-2 infection among healthcare workers in Qatar. (PubMed, J Infect Public Health) - "Recent influenza vaccination is associated with a significant reduction in the risk of SARS-CoV-2 infection and COVID-19 severity."

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

Enhanced passive safety surveillance of Influvac® and Influvac® Tetra: Results from seven consecutive seasons. (PubMed, Vaccine) - "The EPSS set up for Influvac® and Influvac® Tetra proved a robust and effective methodology to comply with the objectives of EMÁ's guidance on enhanced safety surveillance of seasonal influenza vaccines. Safety data from seven consecutive seasons confirmed the favourable safety profile of both vaccines."

Journal • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

Results from the Enhanced Passive Safety Surveillance for the influenza vaccine Influvac Tetra in Germany during 2021/2022 vaccination season (OPTIONS XI 2022) - No abstract available

Clinical • Infectious Disease • Respiratory Diseases

A pilot study on the effectiveness of Influenza Vaccination to prevent relapse of steroid sensitive nephrotic syndrome in children. (IPNA 2022) - "Objectives:To study the effect of influenza vaccination in children with Steroid Sensitive Nephrotic Syndrome by comparing the frequency of viral Upper Respiratory Tract Infections (URI) and associated relapses from historic controls.Materials and Trivalent, inactivated Influenza vaccine (Influvac 2019/2020) was given to children with steroid sensitive nephrotic syndrome in 2019... There seems to be a significant decrease in all-cause URI and relapses in steroid sensitive nephrotic children who are vaccinated with flu vaccine. Further trials in larger cohorts are required to confirm the beneficial effect of this recommended vaccination."

Clinical • Glomerulonephritis • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases

Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine. (PubMed, Front Immunol) - P2a | "The 90µg and 180µg dose levels were selected to be further evaluated in this randomized, monocenter, reference-controlled (Influvac Tetra™: quadrivalent seasonal influenza subunit vaccine), parallel group, double-blind, Phase 2a study in 300 healthy volunteers, aged 18-65 years, during the 2019/2020 flu season. In conclusion, these results encourage further clinical evaluation of OVX836 in order to confirm the signal of efficacy on ILIs and/or laboratory-confirmed influenza cases. NCT04192500 (https://clinicaltrials.gov/ct2/show/study/NCT04192500)."

Clinical • Journal • P2a data • Immunology • Infectious Disease • Respiratory Diseases • CD4 • IFNG

Exposure to Deoxynivalenol During Pregnancy and Lactation Enhances Food Allergy and Reduces Vaccine Responsiveness in the Offspring in a Mouse Model. (PubMed, Front Immunol) - "Male offspring were injected with Influvac vaccine...In conclusion, early life dietary exposure to DON can adversely influence immune development in the offspring. Consequently, the immune system of the offspring may be skewed towards an imbalanced state, resulting in an increased allergic immune response to food allergens and a decreased immune response to vaccination against influenza virus in these models."

Journal • Preclinical • Allergy • Cholera • Food Hypersensitivity • Immunology • Infectious Disease • Respiratory Diseases

Summary of the National Advisory Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2021-2022. (PubMed, Can Commun Dis Rep) - "The following new recommendations were made: 1) Influvac Tetra may be considered as an option among the standard dose quadrivalent inactivated influenza vaccines (IIV4-SD) offered to adults and children three years of age and older; 2) Fluzone High Dose Quadrivalent (IIV4-HD) may be considered an option for individuals 65 years of age and older who are currently recommended to receive Fluzone High Dose (trivalent); and 3) Flucelvax Quad may be considered amongst the quadrivalent influenza vaccines offered to adults and children nine years of age and older for annual influenza immunization. NACI continues to recommend that an age-appropriate influenza vaccine should be offered annually to anyone six months of age and older who does not have contraindications to the vaccine. Vaccination should be offered as a priority to people at high risk of influenza-related complications or hospitalization, people capable of transmitting influenza to those at high risk of..."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Influenza vaccine for 2021-2022. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Respiratory Diseases

CV-NCOV-011: COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Bayer; N=1000 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases