Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
NCT01364571
Completed
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and... Read More
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
02/28/2019
Locations: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, North Carolina
Conditions: Staphylococcal Infections
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Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
NCT03146403
Terminated
The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
Gender:
ALL
Ages:
All
Trial Updated:
01/29/2019
Locations: UNC Health, Chapel Hill, North Carolina
Conditions: Genital Herpes, HSV-2 Infection
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Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
NCT00224484
Completed
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Gender:
FEMALE
Ages:
Between 10 years and 17 years
Trial Updated:
01/03/2019
Locations: GSK Investigational Site, Raleigh, North Carolina +2 locations
Conditions: Herpes Simplex
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A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
NCT02914275
Completed
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.
Gender:
ALL
Ages:
Between 6 months and 59 months
Trial Updated:
12/30/2018
Locations: Site 429, Asheboro, North Carolina
Conditions: Influenza, Human
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A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
NCT02052726
Completed
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
Gender:
ALL
Ages:
Between 50 years and 85 years
Trial Updated:
11/30/2018
Locations: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary, Cary, North Carolina +1 locations
Conditions: Clostridium Difficile
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Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
NCT01204671
Completed
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Salisbury, North Carolina
Conditions: Influenza
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Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
NCT00614614
Completed
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Gender:
ALL
Ages:
Between 6 weeks and 12 weeks
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Clyde, North Carolina +1 locations
Conditions: Infections, Meningococcal
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Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
NCT01196988
Completed
This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.
Gender:
ALL
Ages:
Between 6 months and 17 years
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Raleigh, North Carolina
Conditions: Influenza
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HerpeVac Trial for Young Women
NCT00057330
Completed
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evalua... Read More
Gender:
FEMALE
Ages:
Between 18 years and 30 years
Trial Updated:
07/26/2018
Locations: GSK Investigational Site, Chapel Hill, North Carolina +1 locations
Conditions: Herpes Simplex Infection
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Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
NCT01230957
Completed
This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives: * To describe the safety profile of subjects in each of the study groups. * To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups. Observational Objective: * To describe the occurrence of first-tim... Read More
Gender:
ALL
Ages:
Between 40 years and 75 years
Trial Updated:
07/13/2018
Locations: Not set, Cary, North Carolina +2 locations
Conditions: Clostridium Difficile Infection, Diarrhea
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Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
NCT01059617
Completed
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
Gender:
ALL
Ages:
Between 19 years and 40 years
Trial Updated:
07/04/2018
Locations: GSK Investigational Site, Salisbury, North Carolina +1 locations
Conditions: Influenza
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Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors
NCT01474174
Completed
This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/02/2018
Locations: Wake Forest University Health Sciences, Winston-Salem, North Carolina
Conditions: Central Nervous System Neoplasm
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