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Influenza clinical trials

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NCT ID: NCT00538213 Completed - Influenza Clinical Trials

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

Start date: October 15, 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 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.

NCT ID: NCT00532298 Completed - Influenza Clinical Trials

Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

Start date: September 20, 2007
Phase: Phase 2
Study type: Interventional

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00531700 Completed - Influenza Clinical Trials

Testing a Personally Controlled Health Record to Ameliorate Influenza at MIT

Indivo at MIT
Start date: October 2007
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. The main study hypothesis is that exposure to more intensive levels of personalized and contextualized information about risk will result in increased knowledge about influenza, greater attributions of immunization safety and efficacy, improved health protecting behaviors including higher levels of appropriate immunization.

NCT ID: NCT00530660 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

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

The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.

NCT ID: NCT00529516 Completed - Influenza Clinical Trials

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

Start date: October 15, 2007
Phase: Phase 3
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 observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.

NCT ID: NCT00527865 Completed - Influenza Clinical Trials

Single Dose Escalating Study of DAS181 in Adults

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

This study will evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Study participants will include up to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or placebo. Participants will remain in the clinic overnight to be watched for health changes for 24 hours after receiving the medication. Study procedures include: physical exams, chest x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs. Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants will be involved in the study for up to 61 days, which includes the screening period.

NCT ID: NCT00524940 Completed - Influenza Clinical Trials

Trial to Describe the Safety and Immunogenicity of Fluzone®

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

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the 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: NCT00522236 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

Start date: June 2007
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: NCT00521586 Completed - Influenza Clinical Trials

Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

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

This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.

NCT ID: NCT00518726 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

Start date: June 2007
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