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Influenza, Human clinical trials

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NCT ID: NCT00197301 Completed - Influenza Clinical Trials

Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.

NCT ID: NCT00197288 Completed - Influenza Clinical Trials

Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

NCT ID: NCT00197223 Completed - Influenza Clinical Trials

Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine

Start date: September 2005
Phase: Phase 3
Study type: Interventional

As a result of the recent supply shortages in the U.S., as well as an anticipated increase in demand during the coming years, GSK Biologicals is pursuing licensure of Fluarix in the U.S. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. GSK proposes to support U.S. licensure of Fluarix with this confirmatory post-marketing study. The purpose of the study is to evaluate the efficacy of a single dose of Fluarix in preventing influenza in adults during the 2005/2006 Influenza season.

NCT ID: NCT00192491 Completed - Influenza Clinical Trials

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, and Varicella Vaccines Administered Concurrently to Healthy Children

Start date: December 2000
Phase: Phase 3
Study type: Interventional

- To compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children who receive an intranasal placebo mist concurrently with MMRIIÒ and VARIVAXÒ (Group 2 vs. Group 1). - To compare immune responses to the three strains of influenza (H1N1, H3N2, and B) following a two dose regimen of FluMist in children who receive the initial FluMist dose concurrently with MMRIIÒ and VARIVAXÒ and in children who receive two doses of FluMist alone (Group 2 vs. Group 3).Secondary: - To assess the safety and tolerability of concurrent administration of FluMist with MMRIIÒ and VARIVAXÒ.

NCT ID: NCT00192413 Completed - Influenza Clinical Trials

Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza

FluMist
Start date: March 2002
Phase: Phase 3
Study type: Interventional

To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.

NCT ID: NCT00192387 Completed - Influenza Clinical Trials

Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)

Start date: September 2001
Phase: Phase 2
Study type: Interventional

The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a single dose of CAIV-T.

NCT ID: NCT00192361 Completed - Influenza Clinical Trials

Trial of the Safety, Transmissibility, and Phenotypic and Genotypic Stability of Influenza Virus Vaccine,(CAIV-T), in Children Who Attend Day Care. (Final Report Version 2.0)

Start date: November 1999
Phase: Phase 3
Study type: Interventional

To assess whether CAIV-T was transmitted from vaccinated children to their unvaccinated contacts in a day care setting; and if so, to estimate the rate of transmission.

NCT ID: NCT00192322 Completed - Influenza Clinical Trials

Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children

CAIVT
Start date: September 2001
Phase: Phase 2
Study type: Interventional

To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA). • To assess nasal swab specimens to detect vaccine virus shedding.

NCT ID: NCT00192309 Completed - Influenza Clinical Trials

Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.

Start date: September 2001
Phase: Phase 2
Study type: Interventional

The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation CAIV-T; Wyeth, Marietta, PA).

NCT ID: NCT00192283 Completed - Influenza Clinical Trials

Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

Start date: September 2000
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.