Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Completed
The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparati... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
06/16/2014
Locations: 325 Omega Medical Research, 400 Bald Hill Road, Warwick, Rhode Island
Conditions: Influenza
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
Completed
The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone.
Gender:
ALL
Ages:
Between 11 years and 18 years
Trial Updated:
01/21/2014
Locations: Omega Medical Research, 400 Bald Hill Road, Warwick, Rhode Island
Conditions: Meningococcal Meningitis
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Completed
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Gender:
ALL
Ages:
65 years and above
Trial Updated:
12/05/2013
Locations: Not set, Warwick, Rhode Island
Conditions: Influenza, Orthomyxovirus Infection, Myxovirus Infection
Study of Quadrivalent Influenza Vaccine Among Adults
Completed
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective: * To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
09/13/2013
Locations: Not set, Warwick, Rhode Island
Conditions: Influenza
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
Completed
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/09/2013
Locations: Roger Williams Medical Center/BUSM, Providence, Rhode Island
Conditions: Lung Cancer
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Completed
Primary Objective: To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects. Secondary Objective: To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
12/13/2012
Locations: Not set, Warwick, Rhode Island
Conditions: Influenza, Orthomyxoviruses, Myxovirus Infection
A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Completed
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after a single injection. * To describe the safety of the candidate vaccines after a single injection.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/26/2011
Locations: Not set, Warwick, Rhode Island
Conditions: Influenza, Swine-origin A/H1N1 Influenza
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
Completed
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to HIV and anti-HIV drugs. Doctors generally treat patients in the early stages of HIV infection with the same anti-HIV drugs taken by patients who have had HIV for a long time. These drugs lower the level of HIV in the blood. However, doctors do not know whether patients... Read More
Gender:
ALL
Ages:
16 years and above
Trial Updated:
03/01/2011
Locations: Mem Hosp of Rhode Island, Pawtucket, Rhode Island
Conditions: HIV Infections
Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Completed
The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
01/19/2007
Locations: Omega Medical Research, Warwick, Rhode Island
Conditions: Influenza