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Influenza 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: 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: NCT00719043 Completed - Influenza Clinical Trials

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

Start date: July 11, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged >=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

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: 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.

NCT ID: NCT00707941 Completed - Influenza Clinical Trials

Oseltamivir Randomised Controlled Efficacy Trial

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

Background In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment < 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, to affect household and community transmission rates. Aims and Objectives This proposal aims to compare the duration of clinical illness among patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset. It will compare the duration of viral shedding among all treatment groups vs placebo, risk of transmission to household contacts by treatment group and whether neuraminidase inhibitor use creates resistance. Secondarily it aims to measure the effect on influenza. Design and Methods A double-blind placebo controlled clinical trial design among a population in an urban slum under current influenza disease burden surveillance will be enrolled. Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to < 48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by PCR and a basic reproductive number calculated (R0). Relevance These findings will address whether oseltamivir can affect illness duration and severity, affect transmission, incidence and resistance in high risk urban Asian settings where a pandemic is most likely to arise.