Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
NCT00391053
Completed
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 demonstr... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
04/12/2016
Locations: Not set, Mesa, Arizona +27 locations
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
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Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
NCT00422292
Completed
This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers. Primary Objectives: * To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine. * To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine. Observational Objectives: Safe... Read More
Gender:
ALL
Ages:
Between 9 months and 12 months
Trial Updated:
04/12/2016
Locations: Not set, Tuscaloosa, Alabama +87 locations
Conditions: Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella
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Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
NCT00483574
Completed
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
Gender:
ALL
Ages:
Between 9 months and 12 months
Trial Updated:
04/12/2016
Locations: Not set, Birmingham, Alabama +79 locations
Conditions: Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella
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Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects
NCT00551031
Completed
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investi... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/12/2016
Locations: Not set, Alabaster, Alabama +28 locations
Conditions: Influenza, Myxovirus Infection
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Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
NCT00561002
Completed
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
Gender:
ALL
Ages:
Between 6 months and 35 months
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza
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Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
NCT00601835
Completed
To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age. To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to the US manufactured... Read More
Gender:
ALL
Ages:
Between 11 years and 60 years
Trial Updated:
04/12/2016
Locations: Not set, Oakland, California +1 locations
Conditions: Diphtheria, Tetanus
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Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
NCT00613509
Terminated
Primary objective: To evaluate the clinical activity of the vaccine regimen, as indicated by progression-free survival versus the clinical activity of the reference treatment. Secondary objectives: Safety: To describe the safety profile in both treatment groups. Efficacy: To determine the objective clinical responses of patients in both treatment groups: complete response and partial response.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/12/2016
Locations: Not set, Tucson, Arizona +18 locations
Conditions: Melanoma, Cancer
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Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults
NCT00623181
Completed
To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age. To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
04/12/2016
Locations: Not set, Grove City, Pennsylvania +1 locations
Conditions: Influenza
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Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®
NCT00755274
Completed
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 ≥... Read More
Gender:
ALL
Ages:
Between 6 months and 5 years
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza, Orthomyxoviridae Infections
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Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
NCT00772109
Completed
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.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/12/2016
Locations: Not set, Hoover, Alabama +48 locations
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
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Study of Safety and Immunogenicity of Fluzone® in Healthy Children
NCT00831675
Completed
To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months
Gender:
ALL
Ages:
Between 6 months and 35 months
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza
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Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
NCT00831987
Completed
To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza
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