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Influenza clinical trials

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NCT ID: NCT01282177 Completed - Influenza Clinical Trials

Influenza Vaccine Safety and Effectiveness in Healthcare Providers

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

The overall objective of this study is to provide ongoing assessment of the safety and effectiveness of seasonal and pandemic H1N1 vaccines in the prevention of ILI (influenza like illness), ILI-associated work absenteeism, and laboratory-confirmed influenza in a cohort of Canadian HCP (Health care providers). Given the uncertainties around the timing of the provision of seasonal influenza immunization to HCP for the 2009/10 influenza season, this study will focus on evaluation of safety and effectiveness of pandemic influenza immunization in Year 1 and evaluation of all recommended influenza vaccines in Years 2 and 3.

NCT ID: NCT01271842 Completed - Quality of Life Clinical Trials

Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study

RESPIFLU
Start date: October 2010
Phase: N/A
Study type: Observational

Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation. To date, no data exist on the outcome of patients having developed acute respiratory distress syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term outcome of survivors of ARDS, the patients included in the observational studies were heterogeneous with various underlying disease. Moreover, no study compared the outcome of survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore conducted this prospective case-control study to compare the long term pulmonary and extra pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for extracorporeal oxygenation (control). Eighteen case patients with inclusion and without non-inclusion criteria were selected from our national registry, and 32 controls (with inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48 patients will be contacted and asked to participate. Patients will be evaluate at least 9 months after ICU discharge, looking for health-related quality of life, measured by the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a static bike will be performed. Muscle weakness will be clinically evaluated by the medical council research (MRC) test, with an additional electromyography if the result of the test was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...). Albumin and prealbumin will be measured to evaluate the nutritional status. Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity lower than patients without extracorporeal oxygenation (15% difference between groups). Inclusion of 13 patients in the case group and 26 patients in the control group will allow testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary outcome measures will be the quality of life, the presence or not of post-traumatic stress disorders, of anxiety and/or depression, the results of pulmonary function testing, of the CT-scan, and of muscle testing. All results will be compared in patients with and without extracorporeal oxygenation.

NCT ID: NCT01270685 Withdrawn - Influenza Clinical Trials

2009 H1N1 Pandemic and Seasonal Influenza in SCI/D: Infection Control Strategies

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

The purpose of this study is to evaluate specific approaches used to prevent/reduce influenza transmission in the SCI/D System of Care in response to the 2009 H1N1 pandemic, including assessing infection control strategies used by SCI staff and guidance provided by local infection control units. Due to the rapid spread of and uncertainties about the H1N1 virus, we will evaluate patient's beliefs, behaviors, and information seeking strategies (e.g., social media). These findings will lend to the understanding of ways to handle emergent issues, such as the H1N1 pandemic, in special populations.

NCT ID: NCT01265914 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety, Tolerability and Immunogenicity of a Universal Influenza A Vaccine

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

The purpose of this study is to investigate the safety, tolerability and immunogenicity of ascending doses of a novel, universal flu vaccine, in healthy volunteers.

NCT ID: NCT01262079 Completed - Influenza Clinical Trials

Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.

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

This is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. This protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the U.S. population early and late in the 2010-2011 influenza season. Immune responses will be evaluated using blood samples. The underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.

NCT ID: NCT01258842 Recruiting - Influenza Clinical Trials

Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults

Start date: December 2010
Phase: Phase 3
Study type: Interventional

To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.

NCT ID: NCT01258595 Completed - Influenza Clinical Trials

A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

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

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: - To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. - To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

NCT ID: NCT01251679 Completed - Influenza Clinical Trials

Household Influenza Transmission Study

HITS
Start date: April 9, 2008
Phase: N/A
Study type: Interventional

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

NCT ID: NCT01249833 Completed - Influenza Clinical Trials

Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

FOCUS
Start date: November 2010
Phase: Phase 4
Study type: Interventional

This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.

NCT ID: NCT01249625 Completed - Influenza Clinical Trials

The Respiratory Protection Effectiveness Clinical Trial

ResPECT
Start date: December 2010
Phase: N/A
Study type: Interventional

Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.