Clinical Trials

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).

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.

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.

The purpose of this study is to provide novel information describing how immune responses to inactivated influenza A/H1N1 vaccine are generated. 

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.

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.

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.

The purpose of this study is to advance the understanding of influenza disease severity in children and adolescents. Also, to investigate if the development of severe disease in young individuals is multifactorial, explained by features of the host innate and adaptive immune responses, and by mismatches between preexisting immunity and pathogen strain.

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.

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.

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.

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.

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.

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.