View clinical trials related to Orthomyxoviridae Infection.
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.
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
Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: - To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. - To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: Immunogenicity: - To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots. - To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine. Secondary Objectives: Immunogenicity: - To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine. Safety: - To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination. - To describe clinical information on some additional defined criteria during the six months following vaccination.
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.
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.
All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). Primary Objective: To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine. Secondary Objectives: - To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain. - To describe the safety profile after the vaccination in each study group - To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency. Observational Objectives: - To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site. - To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group. - To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity. - To evaluate the cellular mediated immune response in a subset of subjects.