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Influenza clinical trials

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NCT ID: NCT00343681 Completed - Influenza Clinical Trials

A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

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

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are: - To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency - To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

NCT ID: NCT00342940 Withdrawn - Influenza Clinical Trials

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

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

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

NCT ID: NCT00337896 Completed - Influenza Clinical Trials

T and B Cell Response to Avian Flu Vaccine

Start date: March 2006
Phase: N/A
Study type: Observational

The purpose of this substudy study is to evaluate the types of cells involved in fighting infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64 years, enrolled at Stanford University Hospital and participating in another clinical trial (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of blood for testing before and approximately one week after each vaccination.

NCT ID: NCT00336453 Completed - Influenza Clinical Trials

Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics

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

The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.

NCT ID: NCT00335855 Withdrawn - Influenza Clinical Trials

Pharma-Pen (Formerly Innoject) Auto-injectory TIV

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

The purpose of this study is to evaluate the safety, effectiveness, and tolerability, of the Pharma-Pen(TM) intramuscular (IM) and subcutaneous (SC) auto-injector systems used by untrained users to self-administer Influenza vaccines as compared to standard IM injections administered by a licensed healthcare professional (e.g. a nurse). Participants will be 120 healthy men and women aged 18 - 50 years who have not received influenza vaccine for at least four years and who have no experience in giving intramuscular or subcutaneous injections. Subjects will be randomly placed in one of three treatment types. They will receive one injection of commercially available Influenza vaccine and will be evaluated over the course of six months.

NCT ID: NCT00334529 Completed - Influenza Clinical Trials

Alternative Oseltamivir Dosing Strategies

Start date: June 5, 2006
Phase: Phase 2
Study type: Interventional

This study will determine if oseltamivir (Tamiflu(Registered Trademark)) is safe and effective given less frequently than the currently prescribed dose of twice a day for 5 days to people who have the flu, and once a day for up to 6 weeks in people who have been exposed to someone else with flu and want to prevent getting it themselves. This study will see if the drug can be given once every other day instead of daily if given with another medication called probenecid (Benemid(Registered Trademark) or Probalan(Registered Trademark)). Healthy people 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to one of the following regimens for 2 weeks: 1) 75 milligrams (mg) of oseltamivir once a day; 2) 75 mg of oseltamivir once every other day plus 500 mg probenecid four times a day; or 3) 75 mg of oseltamivir once every other day plus 500 mg probenecid twice a day. All medications are taken by mouth. On study day 0, subjects have the following baseline procedures: measurement of vital signs, review of medical and medication history, physical examination, blood draw and urine test. They also receive the first dose of oseltamivir or oseltamivir and probenecid. In addition, they undergo the following procedures as follows: - Days 1 and 4: Vital signs; review of clinical symptoms, side effects and medications taken; urine testing and blood draw. - Day 8: Same as day 1 plus count of study medication. - Day 14: Same as day 8 plus pharmacokinetic study to measure the amount of oseltamivir and probenecid in the blood. For this test, a catheter is inserted into an arm vein and blood samples are collected through the catheter before taking the study medications, at the time the medications are taken, and again at 15 minutes, 30 minutes, 45 minutes and 1, 1.5, 2, 4, 8 and 12 hours after the medication is taken. The catheter is then removed. This is the last day to take the study medication. - Day 15: Blood draw for 24-hour (post medication) blood sample. - Day 16: Blood draw for 48-hour (post medication) blood sample. - Days 21 and 28: Same as day 1.

NCT ID: NCT00333398 Completed - Influenza Clinical Trials

Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults

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

The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.

NCT ID: NCT00329966 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

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

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

NCT ID: NCT00329927 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects

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

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

NCT ID: NCT00328107 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Adults

Start date: November 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study was to determine the dose-related safety, immunogenicity, and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults.