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Influenza clinical trials

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NCT ID: NCT00491985 Completed - Influenza Clinical Trials

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

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

This is an open, randomized, multicenter clinical trial. Objectives: - To describe the safety profiles during the 21 days following each primary and booster injection. - To describe the immune response 21 days after each primary and booster injection of each formulation. - To describe the antibody persistence after the first vaccination

NCT ID: NCT00491283 Completed - Influenza Clinical Trials

QuickVue Influenza A+B Clinical Field Trial

Start date: July 2006
Phase: N/A
Study type: Interventional

A comparative study of different swab types used for collection of specimens for rapid inluenza testing

NCT ID: NCT00491257 Completed - Influenza Clinical Trials

A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine

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

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are: - To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. - To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.

NCT ID: NCT00490633 Completed - Influenza Clinical Trials

Intervention Study of Face Mask and Hand Sanitizer to Reduce Influenza Transmission

M-FLU
Start date: October 2006
Phase: N/A
Study type: Interventional

Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.

NCT ID: NCT00488046 Completed - Influenza Clinical Trials

Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

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

Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.

NCT ID: NCT00486980 Withdrawn - Influenza Clinical Trials

Intramuscular Peramivir for the Treatment of Uncomplicated Influenza

Start date: n/a
Phase: Phase 3
Study type: Interventional

This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.

NCT ID: NCT00479648 Completed - Influenza Clinical Trials

A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants

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

Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.

NCT ID: NCT00476307 Completed - Influenza Clinical Trials

Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

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

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® containing the influenza strains recommended for the 2007-2008 season.

NCT ID: NCT00464672 Completed - Influenza Clinical Trials

Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

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

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

NCT ID: NCT00462215 Completed - Influenza Clinical Trials

Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

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

The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.