View clinical trials related to Influenza, Human.
Filter by:A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.
The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with inactivated influenza vaccine can prevent influenza and its complications in other colony members. Furthermore, the study will assess the indirect benefit to Hutterites at high risk of complications. The study is a blinded, cluster randomized controlled trial among Hutterite colonies to test the hypothesis that high immunization rates (>70%) of healthy children with inactivated influenza vaccine reduces transmission of influenza to other colony members. Randomization of these homogeneous, moderately sized colonies where there is regular spread facilitated by a communal lifestyle, but limited re-introduction because of relative isolation from outside community, represents a unique opportunity to test the hypothesis of indirect benefit under close to ideal conditions. The primary outcome will be laboratory-confirmed influenza. Secondary outcomes include influenza-like illness, otitis media, physician visits, antimicrobial prescriptions, absenteeism, lower respiratory tract infection, hospitalizations, and death.
The safety and tolerability of the pandemic A/H5N1 virosomal vaccine formulated with or without the 3rd generation ISCOM™ adjuvant for parenteral administration will be investigated locally and systemically and by using haematological, biochemical and immunological screening tests. The immunogenicity of the H5N1 vaccine will be assessed through the induction of local and systemic antibody and cellular immune responses. In a pandemic situation, an important aspect is the rapidity of the immune response to the H5N1 vaccine so the detailed kinetics of the immune response will be investigated. The capacity of the vaccine to elicit long lasting immunity and cross reactive immunity to H5 viruses will also be evaluated. Furthermore, the quality of the immune response induced by the vaccine will be studied. The vaccine will be administered as twice the normal human dose (30μg HA) with and without adjuvant, and in a dose sparing manor of half (7.5μg HA) and one tenth (1.5μg HA) of the normal human dose with adjuvant. Sixty subjects will receive two doses of virosomal H5N1 influenza vaccine (separated by 21 ± 4 days) by intramuscular injection into the deltoid muscle. Escalating doses will be separated by a period of one week. Four groups each containing 15 subjects will receive two doses of the pandemic virosomal A/H5N1 influenza vaccine containing: Group 1 30µg HA IM, Group 2 1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 3 7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM, Group 4 30µg HA adjuvanted with 50µg 3rd generation ISCOM™ IM.
The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD
Objectives: - To evaluate the safety and tolerability of a prime-boost study regimen that includes the recombinant DNA vaccine followed by licensed 2008/2009 FluLaval(Registered Trademark) in adults ages 18-50 years and adults ages 51-70 years as compared with control groups that receive the licensed vaccine only. - To evaluate whether the study participants in each age group receiving a prime-boost schedule have a greater frequency of H1 or H3 neutralizing antibodies compared with those of the same age group who received only the 2008/2009 trivalent influenza vaccine. - To evaluate differences in antibody or T cell responses (quantity, quality, or durability) between the two groups. Eligibility: - Participants ages 18 to 70 years of age who are available for clinic follow-up through Week 24 and who have no previously undiagnosed clinically significant chronic diseases. Participants will provide blood samples for further testing to determine eligibility. Females must not be or become pregnant during the study. - Volunteers who have been immunized with the current season FDA-approved influenza vaccine (2008-2009), or who are being treated for tuberculosis may not participate. Design: - The study lasts for 24 weeks. - Week 0: The first day of Week 0 (i.e., Day 0) is defined as the day of enrollment and first injection. Specific eligibility is reviewed. Participants will receive an injection of either the DNA vaccine VRC-FLUDNA047-00-VP (at 4 mg dosage) or a placebo. - Week 4: All study participants will receive an injection of the trivalent seasonal influenza vaccine, according to the manufacturer's package insert directions. - Participants will be given 7-day diary cards on which to record temperature and symptoms (e.g., muscle aches, headache, chills, nausea) and injection site reactions (e.g., pain, tenderness). Participants may also enter this information via the Internet. Presence of symptoms may require additional visits to the clinic. - Participants will return to the clinic 2 weeks after each injection for the following procedures: - Blood draws for further tests to determine the immune system's response to the vaccine(s) Clinical evaluations: vital signs and weight, examinations of the lymph nodes, and targeted physical exam on any visit if indicated by interim complaints or laboratory findings.
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
The present study will evaluate the immunogenicity, safety and immunogenicity of two doses of monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.