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Influenza clinical trials

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NCT ID: NCT01698177 Recruiting - Influenza Clinical Trials

Optimizing Influenza Vaccination in Surgical Oncology Patients

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the U.S each year related to the flu. Public health campaigns advocate widespread vaccination for the flu, and especially for high risk people. People with cancer are high risk, with an increased risk of developing complications from the flu, such as pneumonia, bronchitis, or worsening of other medical conditions. As part of their vaccination campaign, the CDC strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly, Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the default is to proceed. Surgical oncologists have several concerns about vaccinating their patients after major surgical procedures. Patients with cancer have impaired immunity, and the ability of our patients to mount an effective immune response to the vaccine is unclear. Conversely, due to their immunocompromised state, our patients may be more susceptible to complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of postoperative complications due to the additional immune challenge of the vaccine. Previous studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ transplantation, but the combination of cancer and major surgery remains unstudied. This is a collaborative study with Infectious Diseases and Microbiology to evaluate the response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon cancers). Patients will be randomly selected to receive the vaccine either 2 weeks preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of ILI and post-op complications will be analyzed. The long term goal of this study is two-fold: to determine the optimal time to vaccinate this group of patients in relation to their surgery, and to improve compliance with vaccination.

NCT ID: NCT01651663 Recruiting - Influenza Clinical Trials

A Study of Arbidol (Umifenovir) for Treatment and Prophylaxis of Influenza and Common Cold

ARBITR
Start date: September 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Arbidol (Umifenovir) is effective in the treatment and Prophylaxis of Influenza and Common Cold

NCT ID: NCT01512056 Recruiting - Influenza Clinical Trials

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

Start date: October 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).

NCT ID: NCT01481467 Recruiting - Influenza Clinical Trials

Evaluation of an Influenza Vaccination Implementation Strategy for Hospital Health Care Workers

Start date: April 2009
Phase: N/A
Study type: Interventional

Influenza is a serious disease which can cause severe illness and even death among patients. Health care workers (HCWs) often get infected with influenza and up to 76% of them keep working while being ill. Immunizing HCWs is therefore an essential factor in protecting patients from influenza as HCWs easily transmit influenza to their patients. However, despite recommendations from the Dutch Health Council since 2007, vaccine uptake among HCWs remains low. The aim of this study is to develop an effective implementation strategy on the basis of previous behavioural studies and to evaluate its value in a clustered randomized trial in all Dutch University Medical Centers (UMCs). Also, we want to assess the program elements that are associated with a higher vaccine uptake and the cost-effectiveness of such an implementation strategy. The results of this study will give more insights in the way influenza vaccination campaigns should be directed in order to achieve high vaccine uptake rates among HCWs in hospitals.

NCT ID: NCT01432340 Recruiting - Influenza Clinical Trials

Seasonal Influenza Vaccine Effectiveness Study in Kenya

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

Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed countries. However, little is know about the effectiveness of influenza vaccine in the developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP) under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya, Lwak (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a three-year influenza vaccine effectiveness study using the commercially available southern hemisphere seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and for 2011 and 2012. The study will evaluate the effectiveness of the vaccine in preventing laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing children with influenza vaccine will decrease influenza-associated acute respiratory infections among children and may reduce the number of non-specific acute respiratory infections in vaccinated children and their household contacts.

NCT ID: NCT01424371 Recruiting - Influenza Clinical Trials

Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)

Start date: November 2011
Phase: N/A
Study type: Observational

This study explores the hypothesis that the use of an adjuvanted influenza vaccine in the elderly will produce greater vaccine effectiveness in their group.

NCT ID: NCT01386424 Recruiting - Influenza Clinical Trials

Screening for LID Clinical Studies Unit Healthy Volunteer Protocols

Start date: July 20, 2011
Phase:
Study type: Observational

Background: - The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases. - Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infections and assist in the development of vaccines and treatments for the infections. These clinical studies include influenza "challenge studies" as well as natural history studies and phase I trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus. - In influenza challenge studies studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu and may also improve treatments for the flu. - Natural history studies and phase I trials of new vaccines are performed so the researchers can learn how some viral infections occur and if new vaccines are safe and potentially effective in preventing the infections. In some of these studies, participants experience insect bites with special clean (non-infected) insects (such as mosquitos) to better understand the role of insects in these infections. Objectives: - To screen healthy volunteers for future CSU studies. Eligibility: - Healthy people between the ages of 18 and 65 Design: - The 3- to 5-hour screening exam includes the following: - Medical history and physical exam - Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests - Standard urine drug testing - Electrocardiogram (ECG) to test heart rhythm and function - Chest x-ray - Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a CSU study or are found to be ineligible to participate. - Volunteers may withdraw from the study pool at any time.

NCT ID: NCT01299142 Recruiting - Influenza Clinical Trials

Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)

Start date: January 2011
Phase: Phase 1
Study type: Interventional

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.

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: NCT01207518 Recruiting - Influenza Clinical Trials

Cluster RCT - Evaluating Effectiveness of a Guide and Tools for Influenza Immunization Campaign Planners

Start date: August 2010
Phase: N/A
Study type: Interventional

During the 2010-2011 and the 2011-2012 seasonal influenza immunization campaigns, we will recruit a minimum of 46 healthcare organizations to either conduct their campaigns as usual or to use the "Successful Influenza Immunization Campaigns for Healthcare Personnel: A Guide for Campaign Planners and a web-based grab-and-go Tool Kit. At the end of the campaign season we will evaluate the impact of the Guide and web-based tools and assess whether there were changes in immunization rates within each organization and/or if there were significant changes in the management of the campaigns across organizations. Following completion of the study, we will work with partner organizations to make these tools available to all Canadian healthcare organizations.