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Influenza clinical trials

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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: NCT01379937 Completed - Influenza Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Start date: July 28, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

NCT ID: NCT01375985 Terminated - Influenza Clinical Trials

Safety Study of Single Administration Intravenous Treatment for Influenza

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

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-7100, a candidate treatment for influenza.

NCT ID: NCT01357265 Completed - Influenza Clinical Trials

Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects

Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

NCT ID: NCT01356342 Completed - Influenza Clinical Trials

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.

NCT ID: NCT01356316 Completed - Influenza Clinical Trials

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Each potential subject will be screened before the start of the study to determine their eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be taken from each eligible subject, for baseline titration of circulating anti-HA antibodies. Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse events during the study. At three weeks (±3 days) after the vaccination, subjects will be asked to return to the site for final collection of blood samples.

NCT ID: NCT01355172 Completed - Influenza Clinical Trials

Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

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

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.

NCT ID: NCT01342796 Completed - Influenza Clinical Trials

Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.

NCT ID: NCT01336166 Completed - Influenza Clinical Trials

The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

Start date: July 2009
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

NCT ID: NCT01332578 Completed - Influenza Clinical Trials

A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

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

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.