Active clinical trials for "Influenza, Human"

Background: The influenza A virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills an estimated 36,000 people in the United States each year. In addition, more than 200,000 people are hospitalized for flu-related complications. Influenza A has a substantial health effect on every age group. Currently, treatments are available for influenza A, but there is concern that the rate of complications or even death from this infection is still high despite treatment, and that over time this virus may become resistant to these treatments. Researchers are interested in developing a possible new treatment that uses antibodies against influenza A virus. Objectives: - To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the influenza A virus because they either have been previously infected with the virus or have been vaccinated against the infection. Eligibility: Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood. Individuals must have previously either recovered from influenza infection or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies. Design: Volunteers will undergo apheresis, an outpatient procedure in which researchers will collect plasma containing antibodies against the influenza virus by drawing blood into a special machine that separates blood cells from the liquid portion under sterile conditions and then returns the blood cells to the donor. Volunteers will be screened with blood tests to ensure that they are eligible to participate and donate blood. Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can volunteer to participate in up to 20 sessions. After plasma is collected, it will be tested to ensure that it can be used to safely develop treatments for patients who have influenza A infection.

The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, communication and evaluation of safety data. This study is a commitment to the European Medicines Agency (EMEA), as part of GlaxoSmithKline Biologicals' (GSK Biologicals') risk management plan for pandemic influenza vaccination.

A cohort of 4000 community-dwelling adults is followed to evaluate the effectiveness of the Finnish national A(H1N1)v influenza vaccination campaign in preventing the first episode of laboratory-confirmed A(H1N1)v influenza. The safety of vaccination and the severity of the disease are followed primarily from health care registers. In a subgroup of 200 participants, the humoral and cellular immunogenicity of the vaccine will be studied.

The efficacy of vaccination against influenza in patients with rheumatoid arthritis has been assessed using humoral response. However, the cellular immunity is another important pathway of response to vaccination. The purpose of this study is to evaluate the degree of cellular immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy controls will participate in this study , will undergo a clinical evaluation the day of vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the day of vaccination and 4 weeks later

The ultimate goal of this collaborative, intensive study is to discover new and effective treatments and to develop better vaccines that can be used in future outbreaks of Influenza A. By integrating the information that we will gather, we will create a unique overview of how influenza causes illness and what might be done to improve patient management.

The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.

The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.

The study will be conducted with nasopharyngeal swab specimens collected prospectively from individuals suspected of having an acute respiratory tract infection caused by an Influenza virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot will be tested in real-time using the requisite viral culture reference methods, one aliquot will be used for H1N1 reference testing, one aliquot will be used to extract nucleic acid in real-time, and one aliquot of the UTM will be archived for the purpose of sequencing to confirm Influenza-positive specimens. The extracted nucleic acid and any remaining specimen will be stored at -70°C for later testing by the artus Influenza RG PCR test, or other investigational method(s).

In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases). If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis). METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment. Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below. The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.