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Influenza clinical trials

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NCT ID: NCT00551031 Completed - Influenza Clinical Trials

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

NCT ID: NCT00546585 Completed - Influenza Clinical Trials

Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults

Start date: March 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7 Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.

NCT ID: NCT00545701 Completed - Influenza Clinical Trials

Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: - To describe the immune response 21 days after each vaccination. - To describe the safety profiles following each vaccination.

NCT ID: NCT00545025 Completed - Influenza Clinical Trials

Revaccination With Influenza Vaccine GSK1247446A

Start date: October 15, 2007
Phase: Phase 2
Study type: Interventional

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

NCT ID: NCT00540592 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A

Start date: October 8, 2007
Phase: Phase 2
Study type: Interventional

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.

NCT ID: NCT00540228 Completed - Influenza Clinical Trials

Study to Evaluate an Influenza Vaccine Candidate

Start date: October 5, 2007
Phase: Phase 2
Study type: Interventional

In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.

NCT ID: NCT00539981 Completed - Influenza Clinical Trials

Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

Start date: September 15, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants.

NCT ID: NCT00539864 Completed - Influenza Clinical Trials

Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV

Start date: September 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.

NCT ID: NCT00538512 Completed - Influenza Clinical Trials

Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

FLUVACS
Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.

NCT ID: NCT00538473 Completed - Influenza Clinical Trials

Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

Start date: October 23, 2007
Phase: Phase 2
Study type: Interventional

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 107973 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 107973 (NCT00386113) are eligible for participation in this study.