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Influenza, Human clinical trials

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NCT ID: NCT03814720 Completed - Influenza Infection Clinical Trials

Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans. Objective: To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP). Eligibility: Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014. Design: Participants received 1 or 2 vaccinations by injections (shots) in the upper arm muscle over 4 months. Participants received a thermometer and recorded their temperature and symptoms every day a diary card for 7 days after each injection. The injection site was checked for redness, swelling, or bruising. Participants had 9-11 follow-up visits over 12-15 months. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Participants who reported influenza-like illness had nose and throat swabs for evaluation of viral infection. Some participants had apheresis. A needle was placed into a vein in both arms. Blood was removed through a needle in the vein of one arm. A machine removed the white blood cells and then the rest of the blood was returned to the participant through a needle in the other arm. A separate consent was provided to participants for genetic testing on their samples.

NCT ID: NCT03813966 Completed - Clinical trials for Influenza Viral Infections

Nasal Swab Home Collection Kit (NSHC Kit) Study

Start date: February 7, 2019
Phase:
Study type: Observational

The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).

NCT ID: NCT03789539 Active, not recruiting - Safety Issues Clinical Trials

Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

Start date: June 2, 2018
Phase: Phase 1
Study type: Interventional

This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation. All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.

NCT ID: NCT03787459 Recruiting - Influenza Clinical Trials

Severe Influenza Trial of ARbidol

STAR
Start date: January 18, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200 hospitalized adults and adolescent patients with confirmed severe influenza. Patients should be randomised as soon as possible after screening (no later than 12 hours), providing they are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to meet the inclusion and exclusion criteria will be permitted only once, providing the time from symptom onset to randomization is still within 7 days. Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment). Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the corresponding placebo for arbidol, will be started at the time of randomization.

NCT ID: NCT03784885 Completed - Influenza Infection Clinical Trials

A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult

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

The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.

NCT ID: NCT03778203 Recruiting - Influenza, Human Clinical Trials

Development of Childhood Anti-influenza Immunity

Start date: September 25, 2018
Phase: Phase 4
Study type: Interventional

More information is needed on how children fight off influenza virus, as they are at greater risk for developing severe influenza infection and tend to have weaker responses to influenza vaccination. The purpose of this study is to understand how a child's early exposure to influenza vaccine or infection with influenza virus prepares him or her to combat future infections with this virus. Investigators will learn about how protection develops following an influenza infection or vaccination and the impact this has on future vaccine responses. The information learned may allow us to develop better vaccines against influenza virus in the future.

NCT ID: NCT03777163 Completed - Influenza Clinical Trials

Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine

Start date: April 22, 2019
Phase: Phase 4
Study type: Interventional

The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.

NCT ID: NCT03768596 Completed - Influenza, Human Clinical Trials

Nudging for Vaccination : Efficacity and Acceptability Among Medical Students

Start date: November 7, 2018
Phase: N/A
Study type: Interventional

Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to Richard Thaler for his work on the application of Nudge to the economy. Health professionals are very inadequately vaccinated (25 to 45% of the population). Some studies have shown that a Nudge based on intent implementation can significantly increase vaccination coverage. However, few studies evaluate the acceptability of Nudge or its application to health professionals. The investigators sought to apply a Nudge based on availability heuristics to health professionals, in order to evaluate its effectiveness and terms of behavior adoption (influenza vaccination) and its acceptability. The investigator's hypothesis is that Nudging is both effective and acceptable and that people found nudging more acceptable if they have been exposed to a nudge.

NCT ID: NCT03765437 Completed - Influenza Clinical Trials

Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam

GQM10
Start date: January 15, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.

NCT ID: NCT03757546 Completed - Influenza Clinical Trials

Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections

GIVRE
Start date: December 3, 2018
Phase:
Study type: Observational

The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza virus and Respiratory Syncitial Virus infections in hospitalized adults at a French university hospital.