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Influenza clinical trials

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NCT ID: NCT06076421 Recruiting - COVID-19 Clinical Trials

Equity Evaluation of Fact Boxes on Informed COVID-19 and Influenza Vaccination Decisions - Study Protocol

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

The study aims to evaluate whether evidence-based fact boxes on COVID-19 and influenza vaccination contribute to the decision making of laypeople from different social backgrounds in different educational settings (e.g. medical practices, outreach work). Furthermore, the study will investigate whether evidence-based fact boxes can contribute to more equitable health care by improving shared decision-making.

NCT ID: NCT06048406 Recruiting - Influenza Clinical Trials

Effect of Health Education on Promoting Influenza Vaccination Health Literacy

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The goal of this cluster randomized controlled trial is to evaluate the effect of health education interventions on influenza vaccination rates and health literacy in primary school students in the city of Dongguan in China. Individuals aged 7 to 12 years who are in grades 4-5 in primary schools in Dongguan will be enrolled. 20 primary schools will be randomly selected, with half designated as intervention group schools and the remaining half as control group schools. The intervention group will receive a monthly health education intervention focused on influenza vaccination for 5 months, while the control group will continue with their routine school health education for 5 months. Researchers will compare the differences in influenza vaccination rates and influenza vaccination health literacy levels between the intervention and control groups after 5 months to see if health education can promote influenza vaccination health literacy among primary school students.

NCT ID: NCT06029933 Recruiting - Influenza Clinical Trials

Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

Start date: August 17, 2023
Phase:
Study type: Observational

This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

NCT ID: NCT05968989 Recruiting - Influenza Clinical Trials

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

Start date: August 9, 2023
Phase: Phase 1
Study type: Interventional

Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no single vaccine works well against all flu viruses that can cause illness. Objective: To test an experimental flu vaccine (FluMos-v2) in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. Design: Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed flu vaccine while taking part in this study. FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants will receive a follow-up phone call the following day. Participants will be given a diary card, a ruler, and a thermometer. They will take their temperature every day for 7 days after receiving the shot. They will measure any skin changes at the injection site. They will record their findings and how they feel. Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other follow-up steps. Participants will have 9 other clinic follow-up visits. Blood will be drawn at each visit. Participants should also come to the clinic if they develop flu-like symptoms during the study. Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through a needle in the vein of 1 arm. The blood will run through a machine that separates out the white blood cells. The remaining blood is returned through a needle in the other arm.

NCT ID: NCT05945485 Recruiting - Influenza Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults

Start date: October 16, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, comparator-controlled, dosage escalation study of an intramuscularly administered mRNA-LNP vaccine, DCVC H1 HA mRNA Vaccine, encoding full-length H1 HA of influenza A/California/07/2009 (H1N1), in up to 50 adult volunteers aged 18 to 49 years, designed to assess vaccine safety and immunogenicity at varying doses. Eligible participants will be sequentially enrolled into dosing groups (10 mcg, 25 mcg, 50 mcg, and selected optimal dose) of DCVC H1 HA mRNA Vaccine. Dosing will commence at the lowest dose (10 mcg) and only escalate to the next higher dose if safety concerns are not identified. Up to ten subjects will be enrolled per dosing group. An optimal dosing group will be selected based on safety outcomes from the 10 mcg, 25 mcg, and 50 mcg dosing group. For the optimal dose, the highest dose with no identified safety concerns as determined by the SRC will be selected. This approach will allow determination of an optimal dosing group which will include 10 optimal dose vaccine recipients. Ten separate participants will be enrolled to receive standard quadrivalent inactivated influenza vaccine (IIV4). The primary goal of this study is to assess the safety of two doses of DCVC H1 HA mRNA Vaccine administered intramuscularly in healthy adults (18-49 yrs) at dosage levels of 10 mcg, 25 mcg, and 50 mcg.

NCT ID: NCT05944705 Recruiting - COVID-19 Clinical Trials

Commercially Available Cannabis Products for Immune Support

Start date: November 1, 2023
Phase:
Study type: Observational

This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.

NCT ID: NCT05866237 Recruiting - COVID-19 Clinical Trials

COVID-19 Vaccine Uptake Amongst Underserved Populations in East London

COVER-ME
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This is a randomised controlled feasibility study to evaluate a patient engagement tool (PET) that has been designed for the target population. The PET will be evaluated from previous qualitative data collected from community this feasibility trial. Eligible patients from six GP practises from Tower Hamlets and Newham will be randomised to the intervention or control during the study.

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: NCT05765396 Recruiting - COVID-19 Clinical Trials

SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies

PassiveDetect
Start date: May 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19, Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19, Flu, and/or RSV. The hypotheses are: (H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their usability between the devices. (H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic Respiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those not infected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR and molecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their captured traces in the early identification of disease/illness analyzed by the devices built in algorithms. (H3) In the mid to long-term, this approach will also be explored as a diagnostic system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments. Participants will: - Be consented; - Be screened for COVID-19, Flu, and/or RSV symptoms according to BAMC's current screening procedures; - Have study data collected; - Complete a symptoms questionnaire; - imPulseTM Una and TOR e-stethoscopes examination will be conducted; - Participants will be compensated for completing all study requirements. (Active-Duty personnel must complete the study procedures while off-duty in order to receive compensation.)

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.