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Influenza clinical trials

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NCT ID: NCT00518453 Completed - Influenza Clinical Trials

Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

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

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

NCT ID: NCT00517517 Completed - Influenza Clinical Trials

Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Start date: July 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.

NCT ID: NCT00516035 Completed - Influenza Clinical Trials

Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults

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

Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza.

NCT ID: NCT00514709 Completed - Influenza Clinical Trials

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

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

DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Primary Objectives: - To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth. - To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth. Secondary Objective: - To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

NCT ID: NCT00510874 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

Start date: July 28, 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00506350 Completed - Influenza Clinical Trials

Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

Start date: August 1, 2007
Phase: Phase 2
Study type: Interventional

The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)

NCT ID: NCT00505453 Completed - Influenza Clinical Trials

A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine

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

Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.

NCT ID: NCT00504231 Completed - Influenza Clinical Trials

Intradermal Influenza Vaccine Study in Elders

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

This randomized trial compared the immunogenicity of 60% dose intradermal (ID) influenza vaccination to standard intramuscular (IM) vaccination of full-dose or 60% dose vaccine. Pre- and postvaccination measurements in the hemagglutination inhibition antibody (HAI) titer were compared. Participants who received reduced-dose vaccine were revaccinated with full-dose IM vaccine.

NCT ID: NCT00502593 Completed - Influenza Clinical Trials

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

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

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00492063 Completed - Influenza Clinical Trials

Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

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

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.