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Influenza, Human clinical trials

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NCT ID: NCT00730457 Completed - Influenza Clinical Trials

Phase 1 Safety and Immunogenicity Study in Healthy Adults of VAX125, a Recombinant HA-flagellin Influenza Vaccine

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

Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.

NCT ID: NCT00727428 Completed - Influenza Clinical Trials

Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

Start date: August 5, 2008
Phase: Phase 1
Study type: Interventional

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.

NCT ID: NCT00724997 Completed - Clinical trials for Seasonal Human Influenza

Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers

GHBCS-01
Start date: March 2007
Phase: Phase 1
Study type: Interventional

The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus. This study is performed further to assess local and systemic immune response and to analyse pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.

NCT ID: NCT00722774 Completed - Influenza Clinical Trials

Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine

Start date: n/a
Phase: Phase 1
Study type: Interventional

In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.

NCT ID: NCT00718146 Completed - Influenza Clinical Trials

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

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

This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP) Objectives: - To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96. - To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.

NCT ID: NCT00718120 Completed - Influenza Vaccines Clinical Trials

Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

Start date: July 18, 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity and safety of GSK Biologicals' Trivalent split virion influenza vaccine Fluviral for the 2008-2009 season in adults over the age of 18.

NCT ID: NCT00714285 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

Start date: July 14, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

NCT ID: NCT00711295 Completed - Influenza Clinical Trials

Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

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

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

NCT ID: NCT00710866 Completed - Influenza Clinical Trials

Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

TITRE
Start date: August 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.

NCT ID: NCT00709800 Completed - Influenza Clinical Trials

Pandemic Influenza Plasmid DNA Vaccines (Needle)

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.