View clinical trials related to Influenza, Human.
Filter by:Study Design: This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost, two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1 boost but with different boost intervals, and one group will receive the DNA vaccine twice as prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human administration and will elicit antibody and T cell responses against the H5 protein. The primary objectives are to evaluate the safety and tolerability of the investigational vaccine regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the study vaccine regimens. Product Description: The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade 2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90 microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1 vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System (Biojector) for the DNA vaccine. Subjects: A total of 60 healthy adults, ages 18-60 years will be enrolled. Study Plan: Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups. Subjects and clinicians will be blinded to group assignment until Day 0 following completion of the enrollment. At the point of enrollment the randomly assigned regimen will become known to subjects and clinicians. Subjects will receive either two or three injections on the schedule shown in the schema. The protocol requires five clinic visits and two telephone follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone follow-up contacts for Group 4.
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: - To describe the immune response per age group and vaccine group after vaccination. - To describe the safety of the vaccines per age group and per vaccine group after vaccination.
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household.
The purpose of this observer-blind clinical trial is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in the elderly. Subjects were previously vaccinated (NCT00529516).
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
The purposes of this research study are: 1. to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine 2. to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce laboratory documented influenza in HIV Infected adults.
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).