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Influenza clinical trials

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NCT ID: NCT00783926 Completed - Influenza Clinical Trials

Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.

NCT ID: NCT00782431 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the effectiveness (seroprotection and seroconversion as measured by the hemagglutination inhibition [HI] assay) of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine in adults 50 years of age and older. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or a licensed egg-derived seasonal influenza vaccine. Blood will be drawn from all subjects for a determination of HI antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects will be monitored for adverse events and rises in body temperature until Day 21 and again until Day 180.

NCT ID: NCT00778895 Completed - Influenza Clinical Trials

Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

Start date: November 10, 2008
Phase: Phase 2
Study type: Interventional

Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

NCT ID: NCT00778297 Completed - Influenza Clinical Trials

Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

Start date: November 2007
Phase: N/A
Study type: Interventional

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability. The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.

NCT ID: NCT00776438 Completed - Influenza Clinical Trials

Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

Start date: September 2007
Phase: Phase 2
Study type: Interventional

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: - To describe the immune response per age group and vaccine group after vaccination. - To describe the safety of the vaccines per age group and per vaccine group after vaccination.

NCT ID: NCT00775450 Completed - Influenza Clinical Trials

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Start date: October 2008
Phase: Phase 2
Study type: Interventional

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

NCT ID: NCT00772889 Completed - Influenza Clinical Trials

Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

Start date: October 9, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).

NCT ID: NCT00772109 Completed - Influenza Clinical Trials

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Start date: October 2008
Phase: Phase 3
Study type: Interventional

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: - To demonstrate lot consistency of the Fluzone ID manufacturing process. - To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety - To describe the safety profile of subjects who receive of Fluzone ID.

NCT ID: NCT00771615 Completed - Influenza Clinical Trials

Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years

Start date: October 16, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.

NCT ID: NCT00766285 Withdrawn - Influenza Clinical Trials

High Dose Influenza in Immunosuppressed Subjects

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

Influenza is a common infection of the upper airways and lungs, and is caused by viruses. Cancer patients may need a stronger influenza vaccine than the general population to protect against influenza. The experimental vaccine is designed to be 9 times stronger than the standard vaccine, which may cause a stronger immune response against influenza in patients with a weakened immune system. The goal of this study is to compare the effects of a new experimental influenza vaccine to the effects of the standard influenza vaccine. One hundred bone marrow recipients, adult volunteers from the MD Anderson Cancer Center, 18 years of age or older, will participate in this study. They will be randomly (by chance) assigned to receive 2 doses of either the standard licensed influenza vaccine or the experimental influenza vaccine. Participants will be asked to complete 5 study visits and 3 telephone contacts. Study procedures include blood draws. The duration of participation is about 6 months.