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Influenza, Human clinical trials

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NCT ID: NCT05779020 Recruiting - Influenza, Human Clinical Trials

Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .

Start date: April 25, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.

NCT ID: NCT05765838 Recruiting - COVID-19 Clinical Trials

Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).

NCT ID: NCT05739474 Recruiting - Influenza Clinical Trials

Tolerability, Safety and Immunogenicity Trial of the Flu-M Tetra Vaccine in Children

Start date: January 19, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess tolerability, reactogenicity, safety and immunogenicity of the Flu-M Tetra vaccine as compared to the VaxigripTetra vaccine in terms of prevention of influenza in children aged 6 months to 17 years old inclusive.

NCT ID: NCT05711797 Recruiting - Influenza, Human Clinical Trials

Pharmacokinetic Characteristics of Subjects With Hepatic Insufficiency and Healthy Subjects

Start date: November 2, 2022
Phase: Phase 1
Study type: Interventional

The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects. The main questions it aims to answer are: - Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver dysfunction and healthy subjects with normal liver function matched for age, weight, and sex. - To evaluate the safety and tolerability of ZX-7101A by a single oral dose in subjects.

NCT ID: NCT05704335 Recruiting - Migraine Clinical Trials

InfluenCEF Study: Study on the Headache Associated With Influenza Infection

INFLUENCEF
Start date: December 20, 2022
Phase:
Study type: Observational

The goal of this observational analytic study with a cohort desing is to evaluate the epidemiology, risk factors and clinical phenotype of headache during Influenza infection. The study will be done in collaboration with the Healthcare Sentinel Network of Castile and Leon (Red Centinela Sanitaria de Castilla y León, RCSCYL) and the National Influenza Center of Valladolid (CNGV). First, the historical data of the VIGIRA network of the 2010-2022 flu seasons will be analyzed, assessing the epidemiology and risk factors of headache during Influenza infection; and second, a study with a case series design with prospective follow-up will be carried out for the incident cases of the 2022-2023 and 2023-2024 Influenza seasons, evaluating the clinical phenotype and the duration of the headache.

NCT ID: NCT05702489 Recruiting - Influenza, Human Clinical Trials

A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza

Start date: September 17, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to compare ZX-7101A in Chinese Adults patients with uncomplicated influenza. The main questions it aims to answer are: - The efficacy of ZX-7101A in Chinese Adults patients with uncomplicated influenza. - The safety of ZX-7101A in Chinese Adults patients with uncomplicated influenza.

NCT ID: NCT05666245 Recruiting - Influenza Clinical Trials

DMID 21-0041; Influenza CVD 59000

EMIT-2
Start date: February 20, 2023
Phase: N/A
Study type: Interventional

The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.

NCT ID: NCT05648448 Recruiting - Influenza Clinical Trials

A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza

AD ASTRA
Start date: February 22, 2023
Phase: Phase 2
Study type: Interventional

This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other. AD ASTRA study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator

NCT ID: NCT05616546 Recruiting - Influenza Clinical Trials

Bone Marrow and Peripheral Blood Immune Responses Study

Start date: October 16, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.

NCT ID: NCT05613751 Recruiting - COVID-19 Clinical Trials

Enhancing Protection Against Influenza and COVID-19 for Pregnant Women and Medically at Risk Children

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

Pregnant women and children with chronic medical conditions are at increased risk of hospitalisation, intensive care admission and death from influenza and COVID-19 infections. However, there appears to be a high level of vaccine hesitancy among women of reproductive age. We will develop "nudge" interventions to improve influenza and COVID vaccine uptake and test the effectiveness of the interventions using randomised controlled trials in - pregnant women - medically at risk children.