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Influenza, Human clinical trials

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NCT ID: NCT02610478 Enrolling by invitation - Influenza Clinical Trials

Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

Start date: November 19, 2015
Phase: Phase 3
Study type: Interventional

Background: Most people infected with the influenza virus have mild symptoms. But some get very sick and even die. Antibodies in the part of the blood called plasma fight germs like influenza. Researchers want to see if plasma with high levels of antibodies helps more than plasma with low levels when transfused into people with influenza. They have plasma from people with high levels of antibodies from being infected with influenza or getting the influenza vaccine. They also have plasma with low or no antibodies. Objective: To see if plasma with high levels of antibodies works better than plasma with low levels to treat influenza. Eligibility: People ages 2 weeks and older who are hospitalized for symptoms of influenza Design: Participants will be screened with medical history and blood and urine tests. They may have a nasal wash test for influenza. For this, they get a saline rinse in one nostril. A plastic tube inserted in the nostril collects fluid. The study lasts 28 days. Participants will get routine influenza care. This includes standard drugs and possible chest x-rays. On Day 1, participants will have: Physical exam Blood tests Throat swab 2 doses of plasma with high antibodies or low antibodies by IV catheter (tube) in a vein. On Days 3 and 7, participants will return to the clinic, if no longer hospitalized, for 1-hour visits. The visits include: Medical exam Blood tests Throat swab On Days 2, 14, and 28, participants will be evaluated either at the clinic or by phone. They will talk about their symptoms.

NCT ID: NCT02511002 Enrolling by invitation - Post Influenza Clinical Trials

Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge

Start date: July 17, 2015
Phase:
Study type: Observational

Background: - Influenza is a common viral infection, but it can be deadly for some people. Researchers want to learn more about how the body fights this virus. They want to study this in people who have recently been infected with influenza. They hope this can help them create more effective influenza vaccines. Objective: - To learn about long-term changes in the body s immune system after influenza infection. Eligibility: - People who have completed a previous LID Clinical Studies Unit influenza challenge study or current or prior participation in an LID natural history study and are willing to have samples stored for future research. Design: - Eligible participants will be asked to visit the clinic every 3 months for 2 years. - During each visit, participants will have blood drawn from an arm vein using a needle and a syringe and a nasal sample. - Participants will have a medical history and physical exam and vital signs performed. This will include blood pressure, heart rate, breathing rate, temperature, weight, and finger-measured blood oxygen. They will answer questions about any medicines taken and possible recent illnesses. - If participants have symptoms of influenza, they may have an additional sample taken from the nose. - Participants will complete a health questionnaire once a month on a secure website. Participants may also give their responses over the telephone.

NCT ID: NCT02266277 Enrolling by invitation - Influenza Clinical Trials

System Alignment for VaccinE Delivery (SAVED): Improving Rates of Influenza and Pneumococcal Vaccination Through Patient Outreach, Improved Medical Record Accuracy and Targeted Physician Alerts

Start date: November 2014
Phase: N/A
Study type: Interventional

The goal of this research study is to improve rates of appropriate influenza and pneumococcal vaccination among adults who receive care at a large multi-specialty group practice in central Massachusetts. The investigators plan to conduct a non-blinded randomized controlled trial during flu season 2014-2015 (Cycle 1). A total of 20,000 e-portal users and 10,000 non e-portal users who are identified in the Reliant Medical Group (RMG) Electronic Health Record (EHR) as not being up to date on their influenza vaccines will be randomized. E-portal users will be randomized to receive: - Arm 1: E-portal message with Interactive Voice Recognition (IVR) call - Arm 2: E-portal message with no IVR call - Arm 3: No e-portal message with IVR call OR - Arm 4: No e-portal message with no IVR call (Control, e-portal users) Non e-portal users will be randomized to receive either: - Arm 5: IVR call OR - Arm 6: no IVR call (Control, non e-portal users)

NCT ID: NCT01286285 Enrolling by invitation - Influenza Clinical Trials

Surveillance of Influenza in Paediatric Intensive Care Units in Bavaria

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

The purpose of the study is to assess the number of severe, laboratory-confirmed influenza in children hospitalized to paediatric intensive care units. Furthermore, the proportion of these children from all children hospitalized to paediatric intensive care units with acute respiratory infections will be established.

NCT ID: NCT01277380 Enrolling by invitation - Clinical trials for H1N1 Influenza Virus

Analysis of the Results From Influenza Rapid Test A Positive and H1N1 Real Time RT-PCR

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

The first outbreak of a new H1N1 influenza pandemic originated in the North America in April 2009. As of July 1, 2009, a total of 77,201 cases were accumulated in 103 countries around the world and the mortality rate of was about 0.43%. Alignment and analysis on gene sequences of the new H1N1 influenza virus found that it contains extremely homologous gene composition with that of the swine influenza viruses (swine flu) identified in Europe and North America in last century. Thus the virus strain was later renamed as a novel influenza H1N1. In general, the symptoms caused by the new influenza H1N1 infection was very similar to those resulted from seasonal influenza viral infection. Thus, it is difficult to distinguish the various influenza strains responsible for the infections only by clinical appearance. To compare the accuracy, specificity and sensitivity and speed in identifying the new influenza H1N1 in suspected cases, the investigators extracted RNA from influenza A-positive reactive specimens identified by a Influenza Rapid Test, for a Real-time PCR method to further detect the presence of swine H1 gene. In addition, the titer of H1N1 virus, the color development on the test stripe and clinical symptoms in patients were significantly associated. Finally, Real-time PCR products were subjected to sequence determination to explore potential new influenza pathogenicity, transmissibility and drug usage.

NCT ID: NCT01235000 Enrolling by invitation - Influenza Clinical Trials

TIV Infant/Toddler Response Evaluation - Follow-up for Influenza B Boost

TITRE IIB
Start date: October 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. Current recommendations in Canada are that if an eligible child less than nine years of age has received two doses of influenza vaccine before, then that child only requires a single dose of influenza vaccine in subsequent years of immunization. In a previous study conducted in early 2010 we measured the antibody response to influenza B in children who had previously received two doses of a B/Yamagata kind of virus contained in the 2008-09 influenza vaccine and just one dose of the B/Victoria kind of virus contained in the 2009-10 recommended vaccine. The purpose of this follow-up study is to see if the protection (antibodies in the blood) provided against the influenza B/Victoria kind of virus that was in the 2009-10 vaccine can be improved with another (second) dose of the same B/Victoria kind of virus included in the 2010-11 vaccine. Since influenza B is an illness especially of children, understanding how to best protect children against both kinds of influenza B is important.

NCT ID: NCT01096238 Enrolling by invitation - Influenza Clinical Trials

Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

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

In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified in Mexico and USA and it has continued to spread globally. The rapid global spread of a novel influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009, to declare the first influenza pandemic in 41 years. In Taiwan, a clinical study to assess the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy volunteers has already been completed. In the previous study, we found that a single 15 mcg HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most adults, including those > 60 years of age (>70%). Our current study aims to follow-up subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago. These subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI). The seroconversion is defined as the post-vaccination serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination serum. The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed among the subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.

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: NCT01053377 Enrolling by invitation - Influenza Clinical Trials

A Randomised Controlled Trial on the Effect of Post-exposure Oseltamivir Prophylaxis on Influenza Transmission in Nursing Homes

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

The incidence of severe morbidity and mortality following an influenza infection during the annual influenza epidemics is highest among the elderly population and 90% of influenzaassociated mortality occurs in this group. Vaccination is considered the best preventive intervention available but offers only partial protection. The protective effect decreases with advancing age and existing co-morbidity. Therefore, in spite of high compliance with vaccination, the risk of influenza-related complications among nursing-home residents, is particularly high, and consequently also the associated disease and economic burden. There is debate on the potential health benefit of the antiviral activity of oseltamivir as an effective supplementary intervention to prevent or contain influenza outbreaks in nursing homes. Although effectiveness of post-exposure prophylaxis (PEP) with oseltamivir on preventing transmission has been demonstrated in trials among healthy (mainly unvaccinated) adults and children, effectiveness has not yet been assessed among vulnerable vaccinated highrisk groups, such as the elderly population in nursing homes. If proven (cost)effective, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well.

NCT ID: NCT00758212 Enrolling by invitation - HIV Infections Clinical Trials

Influenza Vaccination at a Reduced Dose Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem

Start date: November 2008
Phase: N/A
Study type: Interventional

Influenza vaccination has proved it's effectiveness over many years of usage including HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV viral load which follows intramuscular injection of the vaccine is of unknown significance over the long run. Mesotherapy is a procedure developed and practiced in france by which a reduced and diluted amounts of antigens is being introduced by multiple intradermal injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for introducing pain medicine and cosmetics.