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Influenza, Human clinical trials

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NCT ID: NCT03739229 Not yet recruiting - Clinical trials for Vaccine Adverse Reaction

Reactogenicity, Safety and Immunogenicity of a LAIV А/17/Hong Kong/2017/75108 H7N9 Influenza Vaccine

Start date: December 3, 2018
Phase: Phase 1
Study type: Interventional

This is a single center phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Hong Kong/2017/75108 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age.

NCT ID: NCT03413228 Not yet recruiting - Influenza Clinical Trials

Nosocomial Influenza Surveillance 2018 - 2022

NOSOGRIPPE
Start date: February 2018
Phase: N/A
Study type: Observational

Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals. The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset. The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds

NCT ID: NCT02996136 Not yet recruiting - Influenza, Human Clinical Trials

Assessment of the Clinical Performance of the ARROW-FLU System

Start date: December 2016
Phase: N/A
Study type: Interventional

The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture of an FDA cleared molecular device. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

NCT ID: NCT02915809 Not yet recruiting - Influenza, Human Clinical Trials

A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

NCT ID: NCT02662426 Not yet recruiting - Influenza Clinical Trials

Lingdancao Granules in the Treatment of Seasonal Influenza

Start date: April 2016
Phase: Phase 3
Study type: Interventional

Name of study: Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about Lingdancao Granules in the Treatment of Seasonal Influenza Objective: Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of seasonal influenza Design: Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo controlled trial Case number: This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects. Qualified participants are randomly divided into experimental drug group (Lingdancao granules group), positive control group (oseltamivir phosphate group) and placebo group, 106 cases in each.

NCT ID: NCT02465190 Not yet recruiting - Clinical trials for Influenza Viral Infections

Effectiveness of Trivalent Inactivated Influenza Maternal Vaccination Among Pregnant Women and Their Newborns in South Africa

Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

This is a case-control study embedded in a surveillance system to determine the effectiveness of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated hospitalised illness in infants <6 months of age.

NCT ID: NCT01677689 Not yet recruiting - Influenza Clinical Trials

Study to Investigate the Efficacy and Safety of Apomivir®

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

Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.

NCT ID: NCT01582633 Not yet recruiting - Influenza Clinical Trials

Assessment of Needle-free Disposable-syringe Jet Injector (DSJI) ID Dose-sparing of Pandemic A H1N1 Influenza Vaccine

Start date: July 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old. Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing. Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects. Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated. The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.

NCT ID: NCT01227798 Not yet recruiting - Influenza Clinical Trials

Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza

Start date: November 2010
Phase: Phase 1/Phase 2
Study type: Interventional

A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the treatment of patients hospitalized with Influenza-like illness caused by a novel swine origin Influenza virus and other circulating Influenza Viruses. The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.

NCT ID: NCT01006681 Not yet recruiting - Influenza Clinical Trials

Vaccination Against Influenza H1N1 in Rheumatic Diseases

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients.