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Effectiveness of Influenza Vaccines in Preventing Pandemic Influenza Virus Infection Among Healthcare Personnel, First Responders, and School Personnel
Rochester, MN
The purpose of this study is to assess influenza vaccine effectiveness (VE) in preventing pandemic influenza virus illness and infection, and to assess the incidence of pandemic influenza virus infection and illness among Health care providers (HCP), first responders (FR) (police, fire, and Emergency Medical Technicians [EMT]) and school personnel (SP).
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A Study Evaluating the Safety and Effectiveness of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) for Adults Hospitalized with Influenza
Rochester, MN
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
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Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza
Rochester, MN
This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.
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Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling
Rochester, MN
The purpose of this study is to provide novel information describing how immune responses to inactivated influenza A/H1N1 vaccine are generated.
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A Study Comparing the Effectiveness and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of giving anti-influenza immune plasma, as an addition to standard of care antivirals, to patients hospitalized with severe influenza A infection.
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A Study to Better Understand the Immune Response to the Flu Vaccine (MF59) and the High Dose Flu Vaccine (HDFlu) in People 65 Years of Age and Older
Rochester, MN
The purpose of this research study is to better understand the immune response to the Adjuvanted Subunit flu vaccine (MF59) and the High Dose flu vaccine (HDFlu) in people 65 years of age and older.
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Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)
Rochester, MN
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.
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A Study to Evaluate a Real-Time Diagnostic Platform for the Detection of Influenza Strains in Saliva
Rochester, MN
The purpose of this study is to develop a colorimetric test for influenza virus detection in a chemically engineered cup/tube. When sample fluid (saliva) is in the tube, the fluid color turning blue indicates a positive result. We are in the process of developing this test, and will test on saliva samples from flu patients.
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A Study to Evaluate Entolimod on Immune System Aging in Healthy Geriatric Subjects Receiving Influenza Vaccination
Rochester, MN
The purpose of this study is to measure changes of the anti- A/H1N1, anti-A/H3N2, and anti-B influenza virus strains serum circulating antibodies (as assessed using hemagglutination inhibition (HAI) assay) levels in elderly patients.
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A Study to Expand Understanding of Coronavirus in U.S. Children (Enrolling by Invitation Only)
Rochester, MN
The purpose of this study is to evaluate the influenza vaccine effectiveness for preventing severe and life-threatening influenza-associated illness in children 6 months to 17 years of age.
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A Study to Collect Blood Samples to Study Immune Response Genes that may be Associated with an Increased Risk of Severe Influenza
Rochester, MN
The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other geneticvariants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
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Study to Evaluate the Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients with Serious Influenza A Infection
Rochester, MN
The purpose of this study is to determine the optimal dose of FLU-IGIV based upon evaluation of safety and pharmacokinetics in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection.
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Influenza and Other Emerging Diseases Registry
Rochester, MN
The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of children requiring hospitalization during a novel epidemic.