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Influenza 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: NCT05755620 Recruiting - Influenza Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of a Single Dose of H1ssF-3928 mRNA-LNP in Healthy Adults

Start date: April 5, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-site, open-label, comparator-controlled dose escalating study of an intramuscularly (IM) administered mRNA-LNP vaccine encoding for (Vaccine Research Center) VRC H1ssF 3928 of up to 50 healthy adult volunteers aged 18 to 49 years, inclusive. This study is designed to assess the safety and immunogenicity of one dose of H1ssF 3928 mRNA Vaccine. Eligible participants will be sequentially enrolled into dosing groups (10 mcg, 25 mcg, and 50 mcg, selected optimal dose) to receive the H1ssF 3928 mRNA Vaccine at the specified dose. A separate group of 10 participants will receive licensed quadrivalent influenza vaccine (IIV4). Subjects receiving IIV4 will be followed for safety but only their immune responses will be compared to those of participants receiving H1ssF 3928 mRNA Vaccine. Dosing of H1ssF 3928 mRNA Vaccine will commence at the lowest dose (10 mcg) and only escalate to the next highest dose if safety concerns are not identified. Up to ten subjects will be enrolled per dosing cohort. Reactogenicity and adverse event (AE) information through Day 7 and clinical laboratory results through Day 8 from the first three dosing groups will guide the selection of an optimal dose group to include 10 subjects who will receive the optimal dose of mRNA-LNP. The primary objective of this study is to assess the safety of a single dose of VRC H1ssF 3928 mRNA-LNP vaccine administered IM in healthy adults, 18-49 yrs, at doses of 10 mcg, 25 mcg, and 50 mcg.

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: NCT05674370 Completed - COVID-19 Clinical Trials

A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

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: NCT05661890 Completed - Influenza Clinical Trials

Seasonal Influenza and Pneumococcal Vaccination in the Elderly

Start date: November 15, 2022
Phase:
Study type: Observational

The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease. This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this. The aim of the study is two phases. 1. Determination of the prevalence of seasonal influenza and pneumococcal vaccination in elderly people over the over the age of 65 living in Ankara. 2. Investigation of socioeconomic characteristics and vaccine indecision and some health-related determinants of vaccination through the case group created based on the preliminary study on the prevalence of seasonal influenza and pneumococcal vaccination in the elderly over the age of 65 living in Ankara. The study, which includes cross-sectional prevalence and retrospective case-control stages, is planned to be carried out with individuals over the age of 65 living in Ankara province between November 1 and December 31, 2022.

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: NCT05645900 Completed - Influenza Clinical Trials

A Clinical Trial of an Quadrivalent Influenza Virus Subunit Vaccine in Chinese Children Aged 6 to 35 Months

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart. Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered. Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection. Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.

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.