Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Completed
The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvan... Read More
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
06/30/2020
Locations: Johnson County Clin-Trials, Lenexa, Kansas
Conditions: Influenza A Virus, H5N1 Subtype
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population
Completed
The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/22/2020
Locations: Johnson County Clin-Trials, Lenexa, Kansas
Conditions: Norovirus
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
Completed
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Gender:
FEMALE
Ages:
Between 18 years and 40 years
Trial Updated:
11/19/2019
Locations: GSK Investigational Site, Lenexa, Kansas
Conditions: Infections, Streptococcal, Streptococcal Infections
Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
Completed
This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). 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 65 to \<86 years. In addition, the study aims to assess the effect of the Staph... Read More
Gender:
ALL
Ages:
Between 65 years and 85 years
Trial Updated:
02/28/2019
Locations: Vince and Associates Clinical Research, Overland Park, Kansas
Conditions: Staphylococcal Infections
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
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: Vince and Associates Clinical Research, Overland Park, Kansas
Conditions: Staphylococcal Infections
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
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, Arkansas City, Kansas +1 locations
Conditions: Herpes Simplex
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 390, Augusta, Kansas +2 locations
Conditions: Influenza, Human
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
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: Vince & Associates Clinical Research, Inc., Overland Park, Kansas +1 locations
Conditions: Clostridium Difficile
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
Withdrawn
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
Gender:
FEMALE
Ages:
Between 18 years and 40 years
Trial Updated:
10/12/2018
Locations: GSK Investigational Site, Newton, Kansas
Conditions: Respiratory Syncytial Virus Infections
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
Completed
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Gender:
ALL
Ages:
Between 55 days and 89 days
Trial Updated:
09/10/2018
Locations: Cotton ONeil Clinical Research, Topeka, Kansas +1 locations
Conditions: Meningococcal Disease, Meningococcal Meningitis
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, Arkansas City, Kansas
Conditions: Infections, Meningococcal
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
Completed
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in adults compared to two other influenza vaccines. This study will also evaluate the lot-to-lot consistency of three vaccine lots.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
08/22/2018
Locations: GSK Investigational Site, Wichita, Kansas
Conditions: Influenza