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Influenza clinical trials

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NCT ID: NCT00321763 Completed - Influenza Clinical Trials

Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

Start date: April 27, 2006
Phase: Phase 2
Study type: Interventional

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

NCT ID: NCT00321373 Completed - Influenza Clinical Trials

Study to Evaluate an Influenza Vaccine Candidate

Start date: May 11, 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

NCT ID: NCT00320346 Completed - Influenza Clinical Trials

Phase II Study of Pandemic Influenza Vaccine

Start date: July 2006
Phase: Phase 2
Study type: Interventional

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

NCT ID: NCT00319098 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

Start date: May 1, 2006
Phase: Phase 3
Study type: Interventional

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

NCT ID: NCT00318149 Completed - Influenza Clinical Trials

Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

Start date: October 10, 2005
Phase: Phase 2
Study type: Interventional

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.

NCT ID: NCT00318058 Completed - Influenza Clinical Trials

Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly Population

Start date: October 3, 2005
Phase: Phase 1
Study type: Interventional

As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a revaccination with the adjuvanted GlaxoSmithKline influenza vaccine administered intramuscularly about 1 year after administration of the first dose of vaccine. For immunogenicity and safety evaluations, subjects who have already received Fluarix™ during the preceeding year will receive a dose of commercial vaccine and will form the control group of this trial.

NCT ID: NCT00316628 Completed - Influenza Clinical Trials

Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.

Start date: June 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.

NCT ID: NCT00311727 Completed - Influenza Clinical Trials

Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine

Start date: October 2005
Phase: N/A
Study type: Interventional

This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.

NCT ID: NCT00311714 Completed - Influenza Clinical Trials

Safety, Tolerability and Pharmacokinetic Study of Biota-CS-8958

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

This study will look at the safety, tolerability and what the body does to CS-8958 given to 40 healthy volunteers 18-55 years old. CS-8958 is a dry-powder investigational drug that is breathed into the lungs through an inhaler device. The researchers will collect information about any problems that volunteers have while taking the drug and about changes in blood pressure and how the heart is working. Volunteers will have breathing tests, physical examinations, and blood samples collected for laboratory tests. The researchers will also look at how much of the medication travels throughout the body versus how much stays only in the lungs. Doses of the medication will be tested at one level and then at higher and higher levels after a safety committee reviews the safety and tolerability information on volunteers prior to the next higher dose being given. Each volunteer will participate for up to 6 weeks from initial screening to the follow up visit and spend 7 days in the clinic.

NCT ID: NCT00311701 Completed - Influenza Clinical Trials

Chart Review of Antivirals for Influenza in Infants

Start date: November 2005
Phase: N/A
Study type: Observational

This retrospective study conducted in Canada and the US involves a chart review to assess the safety of oseltamivir (Tamiflu®) compared to alternate antiviral therapy, amantidine or rimantidine, administered to children less than 12 months of age with diagnosed or suspected influenza. The objectives are to describe the frequency of neurological and all other adverse events possibly related to administration of these antivirals in these infants. Investigators will also compare frequency of adverse events at various doses of oseltamivir in these children. Critical endpoints to be collected include frequency and severity of adverse events, particularly those relating to central nervous system complications. A sub-investigator will travel to each of the participating sites to collect data related to each infant's health prior to becoming ill, health status at time of influenza diagnosis, dosing regimen, reported neurological events post-dosing, and all reported adverse events post-dosing.