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Influenza, Human clinical trials

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NCT ID: NCT00280033 Completed - Influenza Clinical Trials

H5 Adult - Chiron Study of Bird Flu Vaccine

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

This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.

NCT ID: NCT00265161 Completed - Influenza Vaccines Clinical Trials

The Effectiveness of Influenza Vaccine Among Health Care Workers in a Hospital Setting.

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

The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of the influenza vaccine in health care workers (HCW).

NCT ID: NCT00264576 Completed - Clinical trials for Influenza Disease; Flu

Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults

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

The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 < 50 years.

NCT ID: NCT00263900 Completed - Influenza Clinical Trials

TGV:Use of the Quick Diagnostic Test of the Influenza and the Infection With RSV by the Paediatric Emergency Unit

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

The aim of this study is to evaluate the impact of the use of a quick diagnostic test of infection with RSV and influenza virus on the assumption of clinical responsibility of the children consulting at the Paediatric Emergency Unit.

NCT ID: NCT00258934 Completed - Influenza Clinical Trials

Immunogenicity Study of the Influenza Vaccine in Adults

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

All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions. Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes. Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.

NCT ID: NCT00258830 Completed - Influenza Clinical Trials

Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Start date: September 2005
Phase: Phase 4
Study type: Interventional

To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

NCT ID: NCT00258817 Completed - Influenza Clinical Trials

Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

Start date: October 2005
Phase: Phase 4
Study type: Interventional

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.

NCT ID: NCT00253734 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Different Doses of Fluzone® Influenza

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

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

NCT ID: NCT00242424 Completed - Clinical trials for Inactivated Influenza Vaccine

Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age

GRC28
Start date: September 2005
Phase: Phase 2/Phase 3
Study type: Interventional

Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.

NCT ID: NCT00240903 Completed - Influenza Clinical Trials

Revaccination With Subunit Influenza A/Vietnam/1203/2004 (H5N1) Vaccine

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

The purpose of this study is to determine whether having received an H5 vaccine in the past primes the immune system to respond rapidly to another dose of H5 vaccine. One hundred seventeen participants in a previous vaccine study (involving the A/Hong/Kong/97 virus) during the fall of 1998 at the University of Rochester will be eligible to enroll in this study. Participation in this study will up to 64 days and will involve donation of small samples of blood 7, 28, and 56 days after vaccination.