Sanofi H1N1 + TIV - Adults and Elderly
Completed
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will include up to 850 healthy adults, ages 18 and older. Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the seasonal flu shot over 3 study visits... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/26/2012
Locations: Emory Vaccine Center - The Hope Clinic, Decatur, Georgia +4 locations
Conditions: Influenza
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Terminated
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. Secondary objectives: * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elder... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
07/24/2012
Locations: Not set, Birmingham, Alabama +97 locations
Conditions: Influenza
PR1 Vaccination in Myelodysplastic Syndrome (MDS)
Terminated
Primary aim: 1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4 subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and intermediate-1 myelodysplastic syndrome (MDS) patients. Secondary aims: 1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be conv... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/10/2012
Locations: U.T. M.D. Anderson Cancer Center, Houston, Texas
Conditions: Leukemia, Myelodysplastic Syndrome
Study Evaluating Pneumococcal Vaccine in Healthy Infants
Completed
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Gender:
ALL
Ages:
Between 42 days and 98 days
Trial Updated:
07/06/2012
Locations: Not set, New York, New York
Conditions: Healthy Subjects, Pneumococcal Infections
Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
Completed
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in preventing cytomegalovirus in healthy participants.
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
06/21/2012
Locations: City of Hope Comprehensive Cancer Center, Duarte, California
Conditions: Nonneoplastic Condition
S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer
Terminated
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who hav... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
06/11/2012
Locations: MBCCOP - Gulf Coast, Mobile, Alabama +99 locations
Conditions: Lung Cancer
Study of Anti-HIV Therapy Intensification
Completed
The purpose of this study is to see how the body's immune system changes after replacing and adding new anti-HIV drugs to a patient's current anti-HIV therapy. This study will also see whether adding drugs is safe. Patients who take part in A5136 are also eligible to take part in 2 substudies. The purpose of substudy A5140s is to see how many latently infected cells (cells in which the HIV virus survives) are in the lymph node (small, rounded structures that make disease-fighting cells). Substud... Read More
Gender:
ALL
Ages:
All
Trial Updated:
05/17/2012
Locations: University of Colorado Hospital CRS, Aurora, Colorado +2 locations
Conditions: HIV Infections
NicVAX/Placebo as an Aid for Smoking Cessation
Completed
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
05/08/2012
Locations: NicVAX Investigator, Tucson, Arizona +21 locations
Conditions: Smoking Cessation, Smoking, Tobacco Cessation
A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation
Completed
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
05/08/2012
Locations: NicVAX Investigator, Encino, California +24 locations
Conditions: Smoking Cessation
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
Completed
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.
Gender:
ALL
Ages:
Between 18 years and 40 years
Trial Updated:
04/16/2012
Locations: Not set, San Diego, California +5 locations
Conditions: Influenza, Orthomyxoviridae Infections
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Completed
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 describ... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
04/13/2012
Locations: Not set, Alabaster, Alabama +16 locations
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Completed
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Gender:
ALL
Ages:
65 years and above
Trial Updated:
04/09/2012
Locations: Orlando Clinical Research Center, Orlando, Florida +1 locations
Conditions: Clostridium Infections