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Influenza, Human clinical trials

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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: NCT05734040 Completed - Influenza Clinical Trials

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

Start date: May 10, 2023
Phase: Phase 2
Study type: Interventional

The present study OVX836-006 aims principally to: - Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms; - Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ; - Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response; - Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response; - Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies; - Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

NCT ID: NCT05732610 Completed - COVID-19 Clinical Trials

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study

Start date: February 14, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use.

NCT ID: NCT05728970 Suspended - COVID-19 Clinical Trials

Performance Evaluation of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care (POC) Sites

PURSUE
Start date: February 9, 2023
Phase:
Study type: Observational

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 & Flu A/B test in differential detection of SARS-CoV-2, Influenza A (Flu A) and Influenza B (Flu B) at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and/or Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing in the device(s) under evaluation.

NCT ID: NCT05727202 Completed - Clinical trials for SARS-CoV-2 Infection

Project STARFISH - PRJ0002679

STARFISH
Start date: February 20, 2023
Phase:
Study type: Observational

This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.

NCT ID: NCT05720091 Not yet recruiting - Influenza, Human Clinical Trials

Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China

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

The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are: - Quantitative analysis of total fecal and urine radioactivity in healthy subjects after oral administration of [14C]ZX-7101A to obtain human radioactive recovery data and main excretion routes. - Pharmacokinetics of total activity in whole blood and plasma, and distribution of total activity in whole blood and plasma are quantitatively analyzed after oral administration of [14C]ZX-7101A in healthy subjects. - Quantitative analysis of the radioactive metabolites in plasma, urine and feces of healthy subjects with once [14C]ZX-7101A orally administration, identification of the main metabolites of the radioactive metabolites (close to or greater than 10% of the total radioactive AUC in plasma), and determination of the main biotransformation and elimination pathway of ZX-7101A.

NCT ID: NCT05715515 Completed - COVID-19 Clinical Trials

Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device

Start date: January 6, 2023
Phase: N/A
Study type: Interventional

This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively. This study is part of the performance evaluation to support the CE conformity assessment procedures.

NCT ID: NCT05712759 Not yet recruiting - Infection Viral Clinical Trials

Nosocomial Influenza Surveillance of 2022 - 2027 Seasonal Period

NOSOGRIPPE
Start date: February 1, 2025
Phase:
Study type: Observational

Hospital-Acquired Influenza (HAI) is closely linked to the intensity of influenza in the community. HAI is associated with significant morbidity, mortality and extra costs due to prolonged hospital stay. The incidence of laboratory confirmed HAI has been reported rarely. The proportion of HAI among influenza cases was 11.38% (95% Confidence Interval: 5.19%-19.55%) in a meta-analysis of 14 studies. In France, a prospective surveillance study of adults with Influenza-Like Illness (ILI) over 11 years, reported that 35.6% of the influenza cases diagnosed at hospital were hospital-acquired. HAI is transmitted via respiratory droplets and by hand contacts. The spread is facilitated by Health Care Professionals (HCPs), patients and visitors. Prevention and control of HAI is of upmost importance to preserve patient safety and limit the related economic costs. While vaccination of HCPs has been shown to contribute to the reduction of HAI, less is known on the impact of patient vaccination on the risk of HAI during hospitalization. The aim of this study is to describe the hospital-acquired influenza in a french university hospital.

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.