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79 active trials for Influenza

Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and lungs. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. Researchers want to test a vaccine to prevent flu. Objective: To see if the H10 Ferritin vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-70. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed). Participants will get 1-2 injections of the study vaccine in the upper arm. They will stay in the clinic for at least 30 minutes after each vaccination. Participants will keep a diary card for 7 days after each vaccination. They will record their temperature and any symptoms. They will measure any skin changes at the injection site. Participants may have nose and throat secretions, and/or oral mucosal samples, collected with a disposable swab. Participants will have blood drawn. Some participants may have apheresis. A needle is placed into a vein in both arms. Blood is removed through a needle in the vein of one arm. The blood is spun in a machine that separates the white blood cells. The rest of the blood is returned to the participant through a needle in the other arm. Before apheresis, participants weight, pulse, and blood pressure will be checked. Their medical history will be taken. Participants will have 8-10 follow-up visits. Participation will last about 10 months.

Start: October 2020

Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

Studies have showed that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate. The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency.

Start: May 2021

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

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.

Start: January 2021

Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia

Seasonal influenza epidemics are important causes of morbidity and mortality. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. Early therapy with a neuraminidase inhibitor (NAI) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. N-acetylcysteine (NAC) is a modified form of the amino acid cysteine, with anti-oxidant properties. NAC was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. Previous case report showed that high dose NAC, administered as continuous intravenous infusion, was effective and safe in improving the clinical outcomes. We aim to perform a randomized controlled trial to evaluate the therapeutic role of adjunctive NAC in the clinical management of patients with influenza complicated by lower respiratory tract involvement and abnormal respiratory status. Such information when available may reveal the potential of NAC for optimization of management of severe influenza, and provide important insights into future adjunctive therapy research.

Start: July 2021

Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients

This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.

Start: May 2021

Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination

This is a Phase IV open label and single arm study enrolling up to 55 healthy males and non-pregnant females in a single site, 18-49 years old, inclusive. The study is designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. The study duration is up to 4 years. After 1 year, subjects will be offered the opportunity to participate in the study for up to 3 consecutive years provided eligibility criteria is met each year. Subjects who elect to continue in the study after first year of participation will be rescreened to verify continued eligibility and re-consented prior to subsequent participation. The primary study objective is to investigate the longevity of humoral immunity to influenza virus in humans.

Start: December 2015

Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19)

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

Start: January 2021

This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam

This was an extensive, double-blind, randomized, placebo-controlled phase 3 study that aimed to evaluate the safety and immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) in children from 6 months to under 18 years old and the elderly over 60 years old in Vietnam. The main target: Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old. Evaluating the immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) after 1st injection on day 22 (+7) for groups ? 9 years old or day 49 (+7) for groups of 6 months to 8 years for each antigenic component of the vaccine.

Start: September 2020

Influenza Vaccine Responses

The purpose of this research study is to better understand the immune response to the Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65 years of age and older. The research team will be studying why immune response diminishes as people get older in both men and women. The ultimate goal is to understand how flu immunity develops after vaccination. This information may lead to the development of more effective flu vaccines in the future.

Start: August 2018

Infection Tracking in Travellers. The Project Aims to Identify Profiles of Travel-associated Illness and to Follow up on Long-term Sequelae of Arboviral Infections and Malaria

The investigators hypothesize that sex, age, area of exposure and purpose of travel are associated with different travel-related infections. The investigators also hypothesize that certain infections will have long-term sequelae. Health-data will be collected from travellers from Switzerland and Europe. The project starts with a pilot study for 50 travellers, followed by the recruiting of 10,000 travellers. The data collection will be via a mobile App (ITIT). The ITIT App will collect active data from travellers. The participants will download the App after signing an electronic consent form and completing a baseline questionnaire. Then the travellers will answer a short daily questionnaire about illness symptoms during travel. The ITIT App will also collect passive data (GPS localisation, environmental and weather data). The project will provide real-time data on travel-related infections and profile travel illness by age, sex and purpose of travel and also identify outbreaks.

Start: January 2021

Biomarkers for the Prognosis of Influenza in Children

Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms. Hypotheses : The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication) The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.

Start: January 2019

Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

This is a prospective observational study using a mobile study platform (app) that is designed for use on Android phones. Study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. Participants will also report use of prevention techniques on the weekly survey. Mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. The overall goals of the study are to track spread of coronavirus-like illness (CLI), in?uenza-like illness (ILI) and non-speci?c respiratory illness (NSRI) on a near-real time basis and identify speci?c behaviors associated with an increased or decreased risk of developing these conditions.

Start: November 2020

Comparison of Three Licensed Influenza Vaccines

This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.

Start: October 2015

Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age

The primary objective of the study is to compare the clinical efficacy of high-dose quadrivalent influenza vaccine (QIV-HD) to standard-dose quadrivalent influenza vaccine (QIV-SD) in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type. The secondary objectives of the study are: To compare QIV-HD to QIV-SD: in participants 6 months through 35 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B type using a more stringent threshold in participants 6 months through 35 months of age for the prevention of laboratory-confirmed protocol-defined influenza-like illness caused by viral strains similar to those contained in the vaccine. in participants 6 months through 23 months of age for the prevention of laboratory-confirmed influenza illness caused by any influenza A or B types. To compare hemagglutination inhibition (HAI) immune response of QIV-HD to QIV-SD in participants 6 months through 35 months of age To describe the HAI, seroneutralization (SN), and anti-neuraminidase (NA) immune response To describe the immune response to revaccination in Season 3 (Northern Hemisphere) To describe the safety profile of each vaccine

Start: September 2020

A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

A total of 15,000 eligible subjects (or 5,000subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons (2018-2019, 2019-2020, 2020-2021).

Start: November 2018

Immunogenicity of Novel H1N1 Vaccination Among HIV-Infected Compared to HIV-Uninfected Persons

The purpose of this research is to determine the effectiveness of the novel H1Nl influenza (inactivated/killed formulation) vaccine among both HIV-infected and HIV-uninfected persons. The administration of the H1Nl vaccination is not part of the study's procedures, but is being given as part of routine care.

Start: October 2009

Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years

The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.

Start: September 2018

Digital Online Consultations - Effects on Antibiotic Prescribing in Primary Care

BACKGROUND/SIGNIFICANCE: With developments in mobile health and the abundance of smartphones, online consultations have emerged as a popular form of primary care in Sweden. Controversy exists regarding diagnostic accuracy, appropriate prescription of antibiotics, and effects on care-seeking patient behavior following implementation of online consultations. As empirical research is lacking, the investigators seek to evaluate online primary care consultations compared to physical consultations with regards to non-inferiority of antibiotic prescription for chief complaint of sore throat. METHODS: Medical record data is used to identify patients with a chief complaint of sore throat, cough/common cold/influenza, or dysuria after choosing online (DIGI) or physical (PHYSI) consultations. A cohort of patients with similar chief complaints prior to implementation of online consultations was used as a control group (CONTROL). Prospective data from local registries and medical records was gathered 14 days the consultation. The primary outcome was rate of antibiotic prescription after sore throat. Secondary outcomes included patient revisits (including hospital admissions), patient satisfaction, time to physician contact, registered diagnosis, and documentation or Centor Criteria and Urinary Tract Infection (UTI)-Criteria. SIGNIFICANCE: Results will shed light on whether antibiotic prescription differs significantly between digital and physical primary care consultations. Hypotheses may also be generated as to how patients seek care in light of improved availability in a tax-sponsored healthcare system.

Start: March 2018

Recombinant Influenza Vaccination in U.S. Nursing Homes

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

Start: July 2019

Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Elderly

The study is aim to evaluate the Immunogenicity with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine).

Start: August 2020