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Influenza, Human clinical trials

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NCT ID: NCT00133588 Completed - Influenza Clinical Trials

Proteomic Profiling for Influenza

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

The purpose of this study is to evaluate a new method of detecting the flu infection. This method may allow researchers to identify new proteins being made in response to an infection even before symptoms of the infection are present. The goal of this study is not to prevent the flu but to monitor the immune system response. The elderly and those with chronic health problems are at greater risk for complications (i.e., pneumonia, bronchitis [bacterial infection in the lungs], and sinusitis [bacterial infection in the sinuses]) from the flu. Early detection and diagnosis of the flu decreases the number of people with these complications. Participants will include healthy people between the ages of 21-40, between the ages of 60-89, or 90 years and older, who are living in the communities surrounding the 3 study sites in Virginia. There will be 5 study visits, and subjects will participate up to 1 month.

NCT ID: NCT00133536 Completed - Influenza Clinical Trials

A/H5N1 Vaccine in Healthy Children Aged 2-9 Years

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

The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. To look at immune system responses, researchers will test the children's blood before and a number of times after vaccination. Participants will include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive 2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least 2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response from a third vaccination, children will be offered a third dose of the vaccine. Participants will be involved in study related procedures for up to 13 months, including up to 6 study visits, plus a number of telephone calls.

NCT ID: NCT00133523 Completed - Influenza Clinical Trials

FLU-VACS Comparative Study in Adults

Start date: October 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.

NCT ID: NCT00133510 Completed - Influenza Clinical Trials

Influenza Vaccine in Pediatric Transplant Subjects

Start date: November 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine (flu shot). Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study. Study procedures will include a review of medical records, physical examination, and up to 2 flu shots. All participants will receive the flu vaccine. Four weeks after the first flu shot, participants will return to the clinic for a physical exam, blood sample collection, and a second flu shot as recommended. Following each vaccination, parents will be asked to record their children's temperatures and any experienced side effects in a diary card for two weeks. Participants will be involved in study related procedures for up to 8 months.

NCT ID: NCT00133471 Completed - Influenza Clinical Trials

Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.

NCT ID: NCT00129116 Completed - Clinical trials for Haemophilus Influenzae Type b

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

Start date: March 1, 2003
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.

NCT ID: NCT00128167 Completed - Influenza Clinical Trials

Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age

Start date: October 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.

NCT ID: NCT00127855 Completed - Clinical trials for Haemophilus Influenzae Type b

Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

Start date: March 1, 2003
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

NCT ID: NCT00125944 Completed - Healthy Clinical Trials

Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The objective is to assess the safety of bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.

NCT ID: NCT00115986 Completed - Influenza Clinical Trials

A/H5N1in Adult - Aventis

Start date: March 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.