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Influenza clinical trials

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NCT ID: NCT01023711 Completed - Influenza Clinical Trials

Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

Start date: November 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.

NCT ID: NCT01021098 Active, not recruiting - Influenza Clinical Trials

Acute Respiratory Infection Consortium

ARIC
Start date: November 2009
Phase:
Study type: Observational

Recently, the emergence and rapid global dissemination of novel swine-origin influenza A virus (H1N1) with unique epidemiologic characteristics has heightened awareness and concern of this viral pathogen, and its potential for major disruption of both civil and military stability. Although advances in medical and scientific technologies have improved our basic understanding of respiratory disease, many questions about the epidemiology and immunology of ARI remain unanswered. This study plans to initiate a multi-site, multi-disciplinary research collaboration, termed the Acute Respiratory Infection Consortium (ARIC) for the purpose of studying the etiology, epidemiology and immunology of influenza-like illness (ILI) in order to describe the natural history and risk factors for disease, as well as the characteristics of the host immune response. At the core of the ARIC is the proposed observational, longitudinal study of the Natural History Study of ILI among active duty military members, healthy retirees, and their dependents recruited from both inpatient and outpatient settings of military treatment facilities (MTF) in the continental US to be followed for a total of four (4) visits over a 28-day period. Additionally, the investigators also propose to conduct a household-based study of influenza (Family Transmission Study) in which individuals who have a laboratory-confirmed influenza illness will be recruited and enrolled along with their family members for the purpose of studying transmission of influenza within households. Taken together, these studies will establish a longitudinal cohort of ILI among active duty members and their families, as well as a repository of biological specimens relevant to the epidemiology and immunology of infection. Ultimately, these studies will serve as a solid foundation on which future investigations of ARI epidemiology, treatment and prevention can be based.

NCT ID: NCT01014806 Completed - Influenza Clinical Trials

Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults

Start date: November 2009
Phase: Phase 2
Study type: Interventional

- To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. - To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008].

NCT ID: NCT01014091 Terminated - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

Start date: December 1, 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

NCT ID: NCT01011049 Completed - Influenza Clinical Trials

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: - To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: - To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

NCT ID: NCT01010893 Completed - Influenza Clinical Trials

Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Start date: August 2009
Phase: N/A
Study type: Interventional

To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.

NCT ID: NCT01010737 Completed - Influenza Clinical Trials

A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose study of the safety and priming potential of an intramuscular Influenza vaccine (Multimeric-001) injected to elderly volunteers.

NCT ID: NCT01008956 Withdrawn - Influenza Clinical Trials

Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.

NCT ID: NCT01008137 Completed - Influenza Clinical Trials

Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults

Start date: October 2009
Phase: Phase 4
Study type: Interventional

A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).

NCT ID: NCT01007201 Completed - Influenza Clinical Trials

Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population

Start date: October 2009
Phase: N/A
Study type: Interventional

This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6 years, and greater than or equal to 6 years to less than 18 years. In each age strata, all eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart. Following immunization, safety is measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing includes hemagglutination inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.