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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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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Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
NCT00858468
Completed
Primary Objective: To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups. Observational Objective: To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the inve... Read More
Gender:
ALL
Ages:
Between 2 months and 9 months
Trial Updated:
04/12/2016
Locations: Not set, Little Rock, Arkansas +7 locations
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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Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
NCT01011049
Completed
The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/12/2016
Locations: Not set, Hoover, Alabama +44 locations
Conditions: Influenza
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