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Influenza clinical trials

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NCT ID: NCT05009251 Completed - Influenza Clinical Trials

Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

The study team previously demonstrated that patients are more likely to receive flu vaccine after learning that they are at high risk for flu complications. Building on this past work, the present study will explore whether providing reasons that patients are considered high risk for flu complications (a) further increases the likelihood they will receive flu vaccine and (b) decreases the likelihood that they receive diagnoses of flu and/or flu-like symptoms in the ensuing flu season. It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving the flu vaccine or diagnoses of flu and/or flu-like symptoms.

NCT ID: NCT04982913 Completed - Influenza Clinical Trials

Single Dose and Multiple Dose Safety, Tolerability, PK,and Food Effect Study,and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects

Start date: August 24, 2021
Phase: Phase 1
Study type: Interventional

The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects

NCT ID: NCT04978454 Completed - Influenza Clinical Trials

Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain

Start date: August 19, 2021
Phase: Phase 1
Study type: Interventional

An open-label, dose-ranging influenza challenge study in healthy adult volunteers to determine the optimal infection dose and safety of a recombinant H3N2 (A/Texas/ A/Texas/71/2017 (H3N2, clade 3C3a) influenza strain. The goal of this study is to find a challenge virus dose that is safe and can achieve a symptomatic influenza Attack Rate (AR) that will be sufficiently high for utilization in future vaccine or intervention studies. The optimal dose of the three considered is broadly defined as the minimum challenge virus dose that elicits the highest AR without meeting safety-stopping criteria. Additionally, viral recovery, clinical symptoms, and immune responses over the post-challenge period will be described by challenge dose group. This study will last for up to 1 year depending upon the number of challenge cohorts enrolled given the adaptive dose-escalation design. The populations are healthy males and non-pregnant, non-breastfeeding females aged = 18 and < 46 years of age with a serum HAI antibody titer of </=1:40 against influenza A/Texas/71/2017 (H3N2), clade 3C3a. The study will enroll and challenge up to 106 (plus 8 shams) healthy adult volunteers with the H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus challenge strain. The primary objectives are: 1) To determine the optimal infectious dose of a recombinant influenza virus (A/Texas/71/2017 (H3N2), clade 3C3a) to be used as a clinical challenge strain in future vaccine efficacy or intervention studies as assessed by viral shedding and clinical symptoms. 2) To describe viral detection by quantitative and qualitative Reverse Transcription - Polymerase Chain Reaction (RT-PCR) from study subjects at baseline and post-challenge. 3) To document clinical symptoms from self-reported surveys and standardized symptom scales at baseline and post-challenge.

NCT ID: NCT04941092 Completed - Influenza Clinical Trials

Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU

Start date: June 1, 2021
Phase:
Study type: Observational

Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.

NCT ID: NCT04896086 Completed - Influenza Clinical Trials

First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

Start date: May 24, 2021
Phase: Phase 1
Study type: Interventional

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and sometimes the lungs. Vaccines are given to teach the body to prevent or fight infection. Researchers want to study a new vaccine to prevent the seasonal flu. Objective: To see if the FluMos-v1 vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season. Design: Participants will be screened through a separate protocol. Participants will be tested for COVID-19. They may have a pregnancy test. Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine. It will be injected in the upper arm. Participants will complete a diary card for 7 days. They will record any symptoms they have. They will be given a thermometer to check their temperature. They will also be given a ruler to measure any skin changes at the injection site. Participants will have about 10 study visits. They will be asked how they are feeling and if they have taken any medications. They will have blood drawn. Participants will have oral mucosal samples collected using a thin swab. They may have nose and throat secretions collected using a thin swab. Some participants will have optional apheresis. Blood will be removed through a needle in a vein in one arm. A machine will separate the white blood cells. The rest of the blood will be returned through a needle in a vein in the other arm. Participation will last for 40 weeks.

NCT ID: NCT04801888 Completed - COVID-19 Clinical Trials

Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine

Start date: March 23, 2021
Phase: Phase 4
Study type: Interventional

This study is an open-label, single-center, randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine (Vero cell) with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years

NCT ID: NCT04798677 Completed - Covid19 Clinical Trials

Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine

Start date: October 29, 2020
Phase: N/A
Study type: Interventional

The immune system response needs to be forceful but also balanced for a rapid recovery from infection which avoids harmful overreactions. Innate immunity can adapt and respond more efficiently to secondary exposures, thanks to epigenetic and metabolic reprogramming, namely "trained immunity". ABBC1 is a combination of beta-1,3/1,6-glucan with inactivated Saccharomyces cerevisae rich in selenium and zinc for training immunity. ABBC1 includes repurposed synergistic yeast-based ingredients: a unique ß-1,3/1,6-glucan complex and a consortium of probiotic Saccharomyces cerevisiae, rich in Selenium and Zinc. ABBC1 induces trained immunity due to its specific chemical and tridimensional structure: its ß-glucan complex interacts with specific receptors in immune cells, provoking a release of cytokines and priming phagocytosis. Simultaneous activation of these pathways activates innate immunity and counteracts cytokine storm. ABBC1 provides highly bioavailable selenium and zinc, micronutrients with a critical role in an optimal immune responsiveness to allergy, infection, and vaccines. ABBC1 possesses proven microbiome modulating properties, which revert in immune training. Due to its high tolerance, safety and immediate availability, ABBC1 is an ideal candidate for complementary management of geriatric patients with seasonal influenza viruses or COVID-19, or to improve the immune response in the general population receiving the influenza or Covid-19 vaccines. The absence of drug interactions in ABBC1 allows a dosage that is fully compatible with the medication prescribed for all types of patients, including the elderly who are frequently polymedicated, and allows adding an additional therapeutic tool in the fight against the pandemic. This study assesses the benefits of a nutritional supplementation with ABBC1 in volunteers receiving the influenza vaccine during autumn 2020 and the Covid-10 vaccine during winter 2021.

NCT ID: NCT04782323 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

This Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years to determine the appropriate age population for this vaccine. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults. Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.

NCT ID: NCT04736758 Completed - Influenza Clinical Trials

A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza

Start date: January 8, 2021
Phase: Phase 2
Study type: Interventional

Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.

NCT ID: NCT04729764 Completed - Influenza Clinical Trials

Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

Start date: August 27, 2020
Phase: Phase 1
Study type: Interventional

Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die. According to estimates by the US Centers for Disease Control and Prevention in 2018, influenza causes approximately 290,000 to 640,000 deaths worldwide each year. Therefore, the prevention and treatment of influenza has become a serious public health problem.