Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Completed
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of G... Read More
Gender:
ALL
Ages:
Between 6 weeks and 12 weeks
Trial Updated:
02/25/2022
Locations: GSK Investigational Site, Colorado Springs, Colorado
Conditions: Infections, Rotavirus
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
Completed
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.
Gender:
ALL
Ages:
Between 12 months and 15 months
Trial Updated:
12/15/2020
Locations: GSK Investigational Site, Colorado Springs, Colorado
Conditions: Measles; Mumps; Rubella, Measles-Mumps-Rubella Vaccine
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
Completed
The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age
Gender:
ALL
Ages:
Between 6 weeks and 12 weeks
Trial Updated:
12/07/2020
Locations: GSK Investigational Site, Colorado Springs, Colorado
Conditions: Rotavirus Infection, Rotavirus Vaccines
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Completed
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
Gender:
ALL
Ages:
Between 18 years and 70 years
Trial Updated:
03/18/2019
Locations: Clinical Research Advantage, Inc., Centennial, Colorado +2 locations
Conditions: Healthy
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age
Completed
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
09/26/2017
Locations: Lynn Institute of the Rockies, Colorado Springs, Colorado
Conditions: Influenza
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis
Terminated
The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.
Gender:
ALL
Ages:
All
Trial Updated:
02/16/2016
Locations: Patricia A Fodor, PC, Colorado Springs, Colorado
Conditions: Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome
A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Completed
The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations. Primary Objective: * To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-co... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
03/30/2015
Locations: Not set, Aurora, Colorado +2 locations
Conditions: Influenza
Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults
Completed
The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
03/17/2015
Locations: Lynn Health Science Institute, Colorado Springs, Colorado
Conditions: West Nile Fever
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: Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road, Colorado Springs, Colorado
Conditions: Meningococcal Meningitis
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: Memorial Hospital Cancer Center, Colorado Springs, Colorado +3 locations
Conditions: Lung Cancer
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
Completed
The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
Gender:
ALL
Ages:
65 years and above
Trial Updated:
05/16/2013
Locations: Not set, Colorado Springs, Colorado
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, Aurora, Colorado +2 locations
Conditions: Influenza