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Influenza, Human clinical trials

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NCT ID: NCT02019745 Completed - Smoking Clinical Trials

Effects of Tobacco Products on Live Attenuated Influenza Virus (LAIV) Infections in Human Volunteers

Start date: June 2014
Phase:
Study type: Observational

Chronic exposure to (cigarette smoke) CS causes biological changes, including airway remodeling and changes in baseline gene expression profiles at the level of the epithelium. Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells to enhance antiviral gene expression in response to influenza infection and activate host defense responses. While there is a large body of evidence supporting the notion that exposure to CS causes significant changes in host defense responses, which may be linked to permanent changes in epithelial cells at the genomic level, it is not known whether new and emerging tobacco products have similar or distinct effects. Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study will compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS), e-cigarette smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This will be done by analyzing nasal viral titers, antiviral defense responses, inflammatory mediator production, and markers of immune responses for LAIV-induced responses between the different groups of volunteers.

NCT ID: NCT02019732 Completed - Influenza Clinical Trials

Study to Assess the Burden of Mild Outcomes (Physician Office Visits) Due to Influenza in the United States

Start date: January 2013
Phase: N/A
Study type: Observational

This is a database study to quantify the burden of multiple mild outcomes (i.e., those that result in visits to a physician's office) attributable to influenza in the United States, stratified by age group, geographic region and influenza subtype for selected influenza seasons.

NCT ID: NCT02014870 Completed - Influenza A Clinical Trials

Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies. Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).

NCT ID: NCT02008578 Completed - Influenza Clinical Trials

Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

Start date: December 2013
Phase: Phase 1
Study type: Interventional

The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.

NCT ID: NCT02008344 Completed - Influenza Clinical Trials

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

Start date: December 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

NCT ID: NCT01999842 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age

Start date: November 25, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.

NCT ID: NCT01998477 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18 years of age who are at risk of complications of influenza disease due to underlying diseases.

NCT ID: NCT01995851 Completed - Influenza Clinical Trials

Randomized Controlled Trial of LAIV vs TIV Vaccines in Schools

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Start date: October 2013
Phase: N/A
Study type: Observational

Overall, this study will determine (1) the effect of vaccine type (FluMist vs. TIV) on immunization rates, (2) assess the feasibility of school immunization clinics, and (3) inform a larger study to understand the effects of these two vaccines on reducing influenza.

NCT ID: NCT01995695 Completed - Clinical trials for Influenza A Virus, H7N9 Subtype

Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults

Start date: October 2013
Phase: Phase 1
Study type: Interventional

H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later.

NCT ID: NCT01992107 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

Start date: November 2013
Phase: Phase 3
Study type: Interventional

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.