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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Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
NCT00885105
Completed
The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine. Observational Objectives: * To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination. * To describe the safety of the 2005-2006 pediatric f... Read More
Gender:
ALL
Ages:
Between 6 months and 11 months
Trial Updated:
04/12/2016
Locations: Not set, Little Rock, Arkansas +5 locations
Conditions: Influenza
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Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
NCT00258817
Completed
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, 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 2005-2006 pe... Read More
Gender:
ALL
Ages:
Between 6 months and 36 months
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza
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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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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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Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
NCT00258830
Completed
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center f... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/12/2016
Locations: Not set, Norfolk, Virginia
Conditions: Influenza
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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
NCT00835926
Completed
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response at 21 days following injection of the 2003-2004 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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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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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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A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
NCT01258595
Completed
The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse E... Read More
Gender:
ALL
Ages:
Between 50 years and 64 years
Trial Updated:
04/12/2016
Locations: Not set, Idaho Falls, Idaho +4 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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