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Influenza clinical trials

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NCT ID: NCT01089400 Completed - Influenza Clinical Trials

Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

FluBAL
Start date: October 2009
Phase: N/A
Study type: Observational

The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute respiratory distress syndrome and death even in healthy young individuals. The respective roles of viral replication, bacterial infection and immune alterations of the host during such severe influenza H1N1v infection need to be clarified in order to optimize patients care. In this context, we aim to study immune and virological parameters in bronchoalveolar lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections and to peripheral blood immune and virological parameters.

NCT ID: NCT01086566 Completed - Influenza Clinical Trials

Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1 vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and 3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115 volunteers age 18-64 may participate in study related procedures for approximately 7 months.

NCT ID: NCT01083511 Completed - Influenza Clinical Trials

Collection and Extraction of Respiratory Specimens

Start date: March 2010
Phase: N/A
Study type: Observational

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).

NCT ID: NCT01079273 Completed - Influenza Clinical Trials

Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects

Start date: December 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.

NCT ID: NCT01078779 Active, not recruiting - Influenza Clinical Trials

The Chloroquine for Influenza Prevention Trial

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

A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza

NCT ID: NCT01069874 Completed - Influenza Clinical Trials

Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)

ViDiFlu
Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.

NCT ID: NCT01068912 Completed - Influenza Clinical Trials

Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

NCT ID: NCT01067404 Enrolling by invitation - Influenza Clinical Trials

TIV Infant/Toddler Response Evaluation (TITRE)- Follow-up & Focus on Influenza B

TITRE II
Start date: February 2010
Phase: N/A
Study type: Observational

Each winter, viruses belonging to two kinds of influenza A ("A/H1N1" & "A/H3N2") and two kinds of influenza B ("B/Yamagata" & "B/Victoria") can cause illness. The yearly influenza vaccine is designed to protect against both kinds of influenza A but only one or the other kind of influenza B. The vaccine is changed from year to year, meaning it may include one kind of B virus one year and the other kind another year. But because influenza is so hard to predict, sometimes the kind of B virus chosen for the vaccine may not match the kind that is causing illness. The National Advisory Committee on Immunization recommends that all infants and toddlers receive influenza vaccine to protect against their high rates of hospitalization. Infants/toddlers receiving influenza vaccine for the first time must get two doses (prime plus boost) to have a good antibody response. If they have ever before received a single dose of influenza vaccine, then they are recommended to receive only one dose each year afterwards. But we don't know how well previous doses of one kind of influenza B set the stage for good antibody response to a single dose of the other kind of influenza B. This study will try to answer that question in a group of infants/toddlers who last year received two doses of one kind of B virus ("Yamagata"), as part of another study. This year, we will give them a single dose of influenza vaccine that now contains the other kind of B virus ("Victoria") and see how much antibody they make to both kinds. About half these children received a higher amount of influenza vaccine in the previous year's study, so we will also compare their antibody levels on that basis. Since influenza B is an illness especially of children, understanding how to best protect infants/toddlers against both kinds of influenza B is important. This study will help us know if we need to design a new vaccine that not only includes both kinds of influenza A, but also both kinds of influenza B.

NCT ID: NCT01066377 Active, not recruiting - Influenza Clinical Trials

PRIMAGE (Probiotics, Immunity and Ageing)

PRIMAGE
Start date: April 2010
Phase: N/A
Study type: Interventional

Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and partly explains the increased susceptibility for infection in older individuals. Vaccination is recommended to protect older people against influenza, but immunosenescence also reduces the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and which have a long and safe record of use in humans. Often they are taken together with prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria when they reach the lower gut. There is particular interest in the positive influences of pre- and probiotics in older people, who are subject to alteration in gut microflora composition as well as immunosenescence. The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic and probiotic mix on the immune response to influenza vaccination in young and older subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older (65-85y) subjects recruited from the local Reading community. Participants will take a pre- and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently commercially produced, but has been demonstrated to have particular ecological fitness and anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will be selected on the basis of ability to promote optimal growth and survival of this probiotic. After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood, saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response to the vaccination. A wide range of immune parameters will be assessed, taking into account the age-related shifts in immune cell populations.

NCT ID: NCT01063933 Withdrawn - Influenza Clinical Trials

Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental intravenous (within a vein) flu medication, peramivir, in children. Participants will include 63 hospitalized children with confirmed flu. Children will be grouped according to age and younger children will not receive drug until safety data from the groups of older children are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures include: nasal/throat swabs, reporting any experienced side effects, physical examination including assessment of the nervous system, and blood sample collection. Participants will be involved in study related procedures for up to 28 days.