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Influenza clinical trials

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NCT ID: NCT03274310 Completed - Influenza Clinical Trials

FluSAFE: Flu SMS Alerts to Freeze Exposure

Start date: October 6, 2017
Phase: N/A
Study type: Interventional

Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. Non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. Yet, most interventions are delayed because they are not initiated until care is sought. The investigators have demonstrated in one primarily Latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ILI) early in an illness. This early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. Providing education within a text message is a proven successful strategy to influence behavior. Text messaging itself is scalable, low-cost, and can be used in low literacy populations. However, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.

NCT ID: NCT03266237 Completed - Influenza Clinical Trials

The Immune Response to Influenza Vaccinations in Elderly Individuals

Start date: December 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. The project will include a longitudinal study to define immune signatures and multi-parameter profiles associated with frailty and may lead to the identification of predictive markers of evolution to frailty and Immunosenescence in the elderly.

NCT ID: NCT03248960 Completed - Influenza Clinical Trials

Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

Start date: July 27, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture. The secondary aims are to: Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms. Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test. Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.

NCT ID: NCT03239665 Completed - Influenza Clinical Trials

Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

VEPSC
Start date: October 10, 2017
Phase: N/A
Study type: Interventional

The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.

NCT ID: NCT03233217 Completed - Influenza Clinical Trials

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Start date: September 15, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).

NCT ID: NCT03232567 Completed - Influenza Clinical Trials

Single-ascending-dose Study of the Safety and Immunogenicity of NasoVAX

Start date: September 18, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of NasoVAX in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1).

NCT ID: NCT03231995 Completed - Influenza Clinical Trials

Biomarkers for the Prognosis of Influenza in Children

BMIG
Start date: January 15, 2019
Phase: N/A
Study type: Interventional

Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms. Hypotheses : - The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication) - The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.

NCT ID: NCT03186781 Completed - Influenza Clinical Trials

Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults

Start date: October 25, 2017
Phase: Phase 1
Study type: Interventional

Background: Influenza, or "flu", is a very common infectious respiratory disease. Researchers want to develop a vaccine against flu. Vaccines teach the body to fight or prevent an infection. When the body learns to fight an infection, this is called an immune response. In this study, researchers want to test two new vaccines to help the body make an immune response to flu. Subjects received the vaccine injections in the upper arm muscle. One vaccine, the influenza HA Ferritin vaccine (HA-F A/Sing), was given to all subjects with a needle injection. The other vaccine, influenza DNA vaccine (DNA A/Sing), was given to subjects in Group 3 by a needle-free device that uses high pressure to push the vaccine through the skin and into the muscle. Objective: To test the safety and side effects of two new vaccines for prevention of H2 influenza (flu). Eligibility: Part I: Healthy adults ages 18-47 born after 1969. Part II: Healthy adults ages 18-70, but not born in 1966-1969. Design: Volunteers were tested for eligibility in a separate screening protocol. In Part I, all subjects received injections of HA Ferritin vaccine. These subjects were not expected to have H2N2 exposure based on their age and when H2N2 last circulated in the population. Five subjects in Group 1 received one injection of 20 mcg dose vaccine at Day 0 to test if it is safe. Then, five additional subjects in Group 2 received a total of two injections of a 60 mcg dose on Day 0 and 16 weeks later. In Part II, responses were evaluated from adults born before 1966 who may have prior potential exposure to H2N2 influenza as well as adults similar to those enrolled in Part I who are not expected to have H2N2 exposure. Also, Part II compared responses to 2 different vaccine regimens. Group 3 subjects received a DNA influenza vaccine prime at Day 0 and the HA Ferritin vaccine boost 16 weeks later. Group 4 subjects received the HA Ferritin vaccine 2 times, on Day 0 and 16 weeks later.

NCT ID: NCT03180801 Completed - Influenza Clinical Trials

Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model

Start date: August 18, 2016
Phase: Phase 2
Study type: Interventional

FLU-v is a broad spectrum influenza vaccine that targets regions conserved among multiple influenza strains. FLU-v adjuvanted with Montanide ISA-51 was shown to be safe in previous trials. This study aims to assess efficacy of adjuvanted FLU-v vaccine in protecting healthy volunteers against an influenza challenge delivered intranasally under quarantine. Efficacy of FLU-v will be assessed by measuring the incidence and severity of the disease in the treatment groups compared to the placebo group. In addition, the immune responses of the volunteers to FLU-v will also be explored.

NCT ID: NCT03163342 Completed - Influenza Clinical Trials

Immune Response Following Seasonal Influenza Vaccination

Start date: May 8, 2017
Phase: Phase 4
Study type: Interventional

This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.