Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in...
InfluenzaAvianThe purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.
Testing a Personally Controlled Health Record to Ameliorate Influenza at MIT
InfluenzaThe purpose of this project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. The main study hypothesis is that exposure to more intensive levels of personalized and contextualized information about risk will result in increased knowledge about influenza, greater attributions of immunization safety and efficacy, improved health protecting behaviors including higher levels of appropriate immunization.
Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza...
Influenza DiseaseThis phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases
Trial to Describe the Safety and Immunogenicity of Fluzone®
InfluenzaObjective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Objective 3: Serum Collection - 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.
Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza...
InfluenzaIn order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
InfluenzaOrthomyxoviridae InfectionsPrimary Objective: To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®). Secondary Objective: To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine
Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly,...
InfluenzaThe study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV_a in adults and elderly subjects.
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
InfluenzaInfluenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection. Consequently, influenza vaccine has been recommended for children 6-59 months of age. Influenza vaccine is not approved for use in children under 6 month of age who are at highest risk. Therefore, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices has recommended vaccination of household contacts of children under 6 month of age - a cocooning strategy. The current study is a hospital-based study to assess the effectiveness of a program to vaccinate birth mothers and household contacts of newborns with influenza vaccine. We propose to study both birth mothers and household contacts of newborns delivered at Durham Regional Hospital and Duke University Medical Center, birthing hospitals serving Durham and surrounding counties in central North Carolina. We will implement several strategies to increase vaccine coverage rates at Durham Regional Hospital utilizing Duke University Hospital as a comparison setting. Strategies will include: standing vaccine orders for birth mothers, vaccine reminders for household contacts, and a hospital based influenza vaccine clinic to increase vaccine accessibility for household contacts. Vaccine coverage rates will be assessed utilizing a survey method (maternal interview at the birthing hospital and a follow-up telephone contact 6-8 weeks later). We hypothesize that influenza vaccine coverage rates for new mothers and household contacts of newborns delivered at the intervention hospital will be higher when compared to coverage rates in the comparison hospital. Demographic determinants of vaccine coverage and reasons for refusal of influenza vaccine will also be assessed.
Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine
InfluenzaVirus DiseasesIn the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
InfluenzaThe purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.