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.
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 419, Charleston, South Carolina +1 locations
Conditions: Influenza, Human
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
Completed
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
Gender:
ALL
Ages:
Between 6 months and 17 years
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Barnwell, South Carolina
Conditions: Influenza
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
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, Charleston, South Carolina
Conditions: Infections, Meningococcal
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
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, Mount Pleasant, South Carolina
Conditions: Clostridium Difficile Infection, Diarrhea
Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
Completed
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age
Gender:
ALL
Ages:
Between 6 months and 48 months
Trial Updated:
06/11/2018
Locations: Site 102, Charleston, South Carolina
Conditions: Influenza
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Completed
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
07/11/2017
Locations: Rheumatology Associates, Charleston, South Carolina +1 locations
Conditions: Rheumatoid Arthritis
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Completed
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
01/31/2017
Locations: Site 307, Mount Pleasant, South Carolina
Conditions: Influenza, Human
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Completed
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been up... Read More
Gender:
ALL
Ages:
Between 12 months and 15 months
Trial Updated:
10/18/2016
Locations: GSK Investigational Site, Charleston, South Carolina
Conditions: Haemophilus Influenzae Type b, Neisseria Meningitidis
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
Completed
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
Gender:
FEMALE
Ages:
Between 10 years and 17 years
Trial Updated:
09/20/2016
Locations: GSK Investigational Site, Charleston, South Carolina
Conditions: Herpes Simplex
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Completed
The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
05/23/2016
Locations: PMG Research of Charleston, Mt. Pleasant, South Carolina
Conditions: PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM
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, Mt. Pleasant, South Carolina
Conditions: Influenza
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
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, Mt. Pleasant, South Carolina
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection