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Influenza, Human clinical trials

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NCT ID: NCT05594888 Recruiting - Grip Clinical Trials

GRIP: Maximum Isometric Grip Strength Assessed With Three Different Hand-held Dynamometers

Start date: November 17, 2022
Phase:
Study type: Observational

Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. For certain age- and activity-groups, alternative devices may be more appropriate. To date, the quality criteria (test-retest-reliability and validity) of the JAMAR Smart Hand Dynamometer and the Martin Vigorimeter compared to the current gold standard are not yet investigated. Furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.

NCT ID: NCT05521763 Recruiting - Influenza Vaccines Clinical Trials

Influenza Vaccine Uptake Among Healthcare Workers

Start date: March 12, 2022
Phase: N/A
Study type: Interventional

Background: 1. Burden: Health-care workers (HCWs), such as doctors, nurses, and support staff involved in direct or indirect patient care, are at increased risk of influenza virus infections. HCWs may also transmit and spread influenza among hospitalized patients and other caregivers. HCWs often (40-83%) work while experiencing influenza-like illness (ILI), increasing the likelihood of influenza transmission to colleagues and patients. 2. Knowledge gap: Despite the World Health Organization recommendation for seasonal influenza vaccination among priority target groups such as health care workers, the low-income country such as Bangladesh lacks a seasonal influenza vaccination policy among this high-risk group, and vaccine uptake remains low. 3. Relevance: This study aims to generate preliminary data on HCWs willingness to get seasonal influenza vaccines following vaccine availability and factors associated with vaccine uptakes. The data from the study will support policymakers to increase awareness and develop influenza vaccination policy among top priority groups such as health care workers. Hypothesis: The investigators hypothesize that awareness and availability of influenza vaccine supply would increase influenza vaccine uptake among health care workers Objectives: 1. To assess influenza vaccine uptake among healthcare workers (HCWs) following awareness and availability of influenza vaccine supply in study hospitals 2. To explore HCWs barriers and Motivators for influenza vaccine uptake 3. To understand policy makers' perspectives on the feasibility of influenza vaccination among HCWs and to share with the National Immunization Technical Advisory Group (NITAG) for a policy decision regarding influenza vaccination Methods: The study will be conducted at four tertiary-level public teaching hospitals in Bangladesh. The investigators will use a cluster randomized controlled trial design. The intervention will be randomly allocated at the facility level and will include four arms: i) availability of influenza vaccine supply; ii) influenza vaccine awareness; iii) both influenza vaccine supply and influenza vaccine awareness, and iv) control arm with no intervention. The investigators will assess influenza vaccine uptake before and after intervention and between different study arms. The investigators will also explore the barriers and motivators of vaccine uptake using a qualitative approach. To understand the policy makers' perspectives and opinions regarding influenza vaccination among health care workers, the investigators will conduct in-depth interviews. Outcome measures/variables: 1. The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms 2. Different motivators and barriers to influenza vaccine uptake

NCT ID: NCT05518500 Recruiting - Aging Clinical Trials

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

FluVax3
Start date: August 31, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 66 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at each of the sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

NCT ID: NCT05517174 Recruiting - Influenza Clinical Trials

A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

DANFLU-2
Start date: September 22, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.

NCT ID: NCT05494047 Recruiting - Influenza Clinical Trials

Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile

TetraFluVac
Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study compares the immunogenity and safety of quadrivalent inactivated influenza vaccines. The experimental group receives the quadrivalent influenza vaccine developed by Sinovac Biotech Co., Ltd and the control group immunized with Vaxigrip Tetra™. The group has 1600 persons from general population 3 years and older. The design is double-blind and randomized. The primary outcome is the immunogenicity against the 4 strains of influenza included in both vaccines.

NCT ID: NCT05479370 Recruiting - Clinical trials for Influenza Vaccination

Immunogenicity Trial of 3 Influenza Vaccines

Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

This study is a prospective randomised trial of 3 influenza vaccine formulations with different manufacturing processes: 1) egg-grown (QIV-E); 2) cell-grown (QIV-C); and 3) recombinant protein (QIV-R). The main objective is to compare the antibody responses following influenza vaccination among these 3 vaccines to determine whether recombinant vaccines offer superior protection over standard egg or cell-based formulations. The attenuating effects of prior vaccination on vaccine immunogenicity will also be evaluated. Hypothesis: Vaccination with recombinant vaccine results in better antibody responses, particularly against A(H3N2) viruses, than either standard egg-grown vaccines or cell-grown vaccines.

NCT ID: NCT05436444 Recruiting - Influenza Infection Clinical Trials

Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model

Start date: October 23, 2023
Phase: Phase 1
Study type: Interventional

Background: Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu. Objective: To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work. Eligibility: Healthy adults age 18-50. Design: Participants will be screened with: Physical exam with vital signs and weight Medical and medicine review Blood and urine tests Electrocardiogram to measure the heart s electrical activity. Screening tests will be repeated during the study. Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose. Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors. Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity. One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms. Participants will be discharged after they have 2 consecutive negative tests for flu. Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks.

NCT ID: NCT05436184 Recruiting - Influenza Clinical Trials

Influenza IMPRINT Cohort: Defining the Impact of Initial Influenza Exposure on Immunity in Infants

Start date: October 17, 2019
Phase:
Study type: Observational

The primary aim is to define the immune responses to the infant's initial influenza exposure (vaccine or infection) and how that affects the immune response to subsequent influenza exposures

NCT ID: NCT05384288 Recruiting - Pediatric Cancer Clinical Trials

Response to Influenza Vaccination in Pediatric Oncology Patients

Start date: October 7, 2022
Phase:
Study type: Observational

Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine. Primary Objective - To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. - To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients. Secondary Objectives - To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients. - To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients. Exploratory Objectives - To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients. - To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.

NCT ID: NCT05375006 Recruiting - Coronavirus Clinical Trials

Tropism and Pathogenesis of Influenza Virus and Coronavirus in Human Brain Explant Culture

COVID-19
Start date: May 26, 2022
Phase:
Study type: Observational

Background: Influenza and coronavirus have been repeatedly causing pandemic recently. Like the Influenza A/H7N9 virus has caused five epidemics in China since its first detection in East China in 2013. In 2017, the previously low pathogenic avian influenza (LPAI) H7N9 virus underwent mutation in its haemagglutinin to give to a highly pathogenic avian influenza (HPAI) virus causing 32 human cases and potentially poses a threat to animal and human health. More recently, the SARS-CoV-2 pandemic has been heavily affecting the world. Therefore an effective risk assessment platform is urgently required for better pandemic preparation. Hypothesis: The tissue tropism and pathogenesis of a newly emerged infectious viruses, like the highlypathogenic influenza, like H7N9 and coronavirus, like SARS-CoV-2 would be different from that of their low pathogenic subtype and it would infect and replicate the human respiratory system more efficiently. Because of its resistance to oseltamivir for influenza and no effective antiviral for coronavirus, investigators therefore propose to set up an novel and effective risk assessment platform for emerging infectious viruses. Experimental Design: The tissue tropism and viral replication kinetics of a HPAI and LP influenza and coronavirus will be determined in ex vivo cultures of human brain and compared with their LP subtype. The replication competence and innate immune responses of influenza and coronavirus will be studied and compared with other LP virus in in vitro cultures of human brain cells and human microvascular endothelial cells (HMVEC) both isolated from human brain tissues. Expected outcomes: HPAI influenza and coronavirus particularly SARS-CoV-2 will infect and replicate the human brain tissues and cells more efficiently than their LP subtype. Besides, HPAI influenza and SARS-CoV-2 will induce dysregulated host innate immune response than the LP subtype.