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Influenza, Human clinical trials

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NCT ID: NCT06294262 Recruiting - Clinical trials for Vaccination Reaction

Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine

TETRALITE-Ib
Start date: January 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics.

NCT ID: NCT06280144 Recruiting - Clinical trials for Influenza Prevention

Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine

Start date: September 22, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine. To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

NCT ID: NCT06278324 Recruiting - COVID-19 Clinical Trials

Effectiveness of a Nasal Spray on Viral Respiratory Infections

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation. The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves. This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment.

NCT ID: NCT06259487 Recruiting - Heart Failure Clinical Trials

Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.

VACCINE-CHF
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure. The main question it aims to answer is: • Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?

NCT ID: NCT06254820 Recruiting - Influenza B Clinical Trials

Dose, Safety, and Pathogenicity of a New Influenza B Strain

Start date: October 3, 2023
Phase: Phase 2
Study type: Interventional

This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.

NCT ID: NCT06207929 Recruiting - COVID-19 Clinical Trials

Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections

WAVE
Start date: January 21, 2024
Phase:
Study type: Observational

The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics.

NCT ID: NCT06205641 Recruiting - Influenza A Clinical Trials

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A

Start date: January 2024
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, randomized controlled trial and aims to evaluate efficacy and safety of Xuanfei Baidu Granule in the treatment of influenza A. This study plans to enroll 584 subjects. The subjects will be randomly divided into 4 groups according to the ratio of 1:1:1:1, and they will be treated with Xuanfei Baidu Granule Placebo, Xuanfei Baidu Granule, Xuanfei Baidu Granule combined with Baloxavir Marboxil tablet.1 bag of Xuanfei Baidu Granule and Xuanfei Baidu Granule Placebo in the morning and evening, and take with boiling water for 5 days. Baloxavir Marboxil Tablet was taken orally 2 tablets, once a day for 1 day. The subjects were visited every day for 7 days after enrollment.

NCT ID: NCT06191393 Recruiting - Clinical trials for SARS-CoV-2 Infection

SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Flu A, and/or Flu B.

NCT ID: NCT06183229 Recruiting - Influenza Clinical Trials

Cycloferon for Post-exposure Prophylaxis of Acute Respiratory Viral Infections and Influenza

Start date: September 15, 2023
Phase: Phase 3
Study type: Interventional

Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.

NCT ID: NCT06179446 Recruiting - Influenza Clinical Trials

A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

Start date: December 13, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: - between the age of 18 to 49 years old. - willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures. - healthy as confirmed by medical history, physical examinations, and the study doctor. - capable of signing informed consent. Participants will receive either: - the pdmFlu Vaccine, - a licensed Influenza Vaccine (QIV) - a placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm at day 1 and at day 21. The study will compare participant experiences to help understand if the pdmFlu Vaccine is safe and effective. Participants will take part in this study for up to 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.