View clinical trials related to Influenza, Human.
Filter by:To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.
This is a sequential phase I and II, controlled, double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children by two reduced doses one month apart of 0.1 mL of a trivalent inactivated influenza vaccine (INF) administered by the intradermal (ID) route with an investigational ID spacer on a United States (U.S.)-licensed needle-free jet injector (JI), compared to two standard intramuscular (IM) 0.25 mL doses by needle-syringe (N-S) in this age group. The locale is a developing country where financial restraints for the use of full-dose influenza vaccine would limit protection from an influenza pandemic threat, where N-Ss pose dangers and drawbacks in clinical use, and where Mantoux-type N-S ID injections are difficult to administer during mass campaigns.
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects previously vaccinated with Fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either Fluarix or the adjuvanted vaccine.
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
The purpose of this study is to look at changes that occur in blood and nasal swab samples after a person's immune system responds to receiving a flu vaccine. The investigators will look at the immune response in 50 healthy volunteers, between 21 and 49 years of age, after they have been vaccinated with 1 dose of a flu vaccine sprayed into the nose. A blood sample and nasal swab of each nostril will be collected from volunteers before they receive the flu vaccination. After receiving the flu vaccine, volunteers will record health changes and daily temperatures on diary cards at home for 21 days. Blood will be drawn and nasal swabs will be collected from each volunteer at each of the 6 study visits. Volunteers will participate in the study for approximately 1 month. This study is being conducted at the Glennan Center for Geriatrics and Gerontology at Eastern Virginia Medical School.
The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process. Secondary Objectives: Immunogenicity To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers. To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96). Safety: To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile. To describe the safety profile after vaccination. Comfort of the vaccination assessment: To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.
Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population. Primary Objective: To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination. Secondary Objectives: Immunogenicity: To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects. To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects. Safety: To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions. To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.