View clinical trials related to Orthomyxoviridae Infections.
Filter by:This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: - To demonstrate lot consistency of the Fluzone ID manufacturing process. - To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety - To describe the safety profile of subjects who receive of Fluzone ID.
Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to < 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to < 5 years of age.
This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP) Objectives: - To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96. - To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Primary Objective: To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years. Secondary Objective: To evaluate the safety profile during the 21-day period following each vaccination in each study group
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Primary 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
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies. Objectives: - To describe the immune response 21 days after each vaccination. - To describe the safety profiles following each vaccination.
This is an open, randomized, multicenter clinical trial. Objectives: - To describe the safety profiles during the 21 days following each primary and booster injection. - To describe the immune response 21 days after each primary and booster injection of each formulation. - To describe the antibody persistence after the first vaccination
This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are: - To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. - To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection.