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Influenza, Human clinical trials

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NCT ID: NCT00363870 Completed - Influenza Clinical Trials

A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

NCT ID: NCT00363077 Completed - Influenza Clinical Trials

Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

Start date: October 2, 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

NCT ID: NCT00356798 Completed - Influenza Clinical Trials

Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects

Start date: December 2005
Phase: Phase 1
Study type: Interventional

Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.

NCT ID: NCT00354016 Completed - Influenza Clinical Trials

Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Start date: July 2006
Phase: Phase 3
Study type: Interventional

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

NCT ID: NCT00349141 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Start date: June 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.

NCT ID: NCT00349037 Completed - Influenza Clinical Trials

Study of the Ability of a Flu Vaccine to Prevent Flu Infection

Start date: September 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body

NCT ID: NCT00347529 Completed - Clinical trials for Influenza (Pandemic)

Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu

NCT ID: NCT00345904 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

Start date: July 2006
Phase: Phase 3
Study type: Interventional

Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years. This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.

NCT ID: NCT00345683 Completed - Clinical trials for Meningococcal Infection

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

Start date: July 2007
Phase: Phase 3
Study type: Interventional

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00345579 Completed - Clinical trials for Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007