Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Completed
Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be inject... Read More
Gender:
ALL
Ages:
Between 18 years and 38 years
Trial Updated:
01/13/2021
Locations: Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri
Conditions: Smallpox
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, Kansas City, Missouri
Conditions: Measles; Mumps; Rubella, Measles-Mumps-Rubella Vaccine
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
Completed
The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Gender:
ALL
Ages:
Between 12 months and 15 months
Trial Updated:
12/15/2020
Locations: GSK Investigational Site, Kansas City, Missouri
Conditions: Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Terminated
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.
Gender:
ALL
Ages:
Between 18 years and 85 years
Trial Updated:
12/11/2020
Locations: Center for Outpatient Health, Saint Louis, Missouri +5 locations
Conditions: Staphylococcal Vaccine
Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer
Completed
This phase II trial studies the side effects and how well vaccine therapy works in treating patients with cervical cancer that does not go to remission despite treatment (persistent) or has come back (recurrent). Vaccines therapy may help the body build an effective immune response to kill tumor cells.
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
08/21/2020
Locations: Washington University School of Medicine, Saint Louis, Missouri
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical Carcinoma
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Completed
Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
07/28/2020
Locations: Center for Pharmceutical Research, Kansas City, Missouri
Conditions: Plague Vaccine
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Completed
This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.
Gender:
ALL
Ages:
65 years and above
Trial Updated:
07/20/2020
Locations: Center for Pharmaceutical Research, LLC, Kansas City, Missouri +1 locations
Conditions: Influenza, Human
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Completed
This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX. Funding Source - FDA Office of Orphan Product Development (OOPD)
Gender:
ALL
Ages:
18 years and above
Trial Updated:
05/05/2020
Locations: Washington University School of Medicine, Saint Louis, Missouri
Conditions: Metastatic Pancreatic Adenocarcinoma
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: St. Louis University, School of Medicine, Saint Louis, Missouri
Conditions: Norovirus
The Safety, Tolerance, and Immunogenicity of MAS-1-Adjuvanted Seasonal Inactivated Influenza Vaccine (MER4101)
Unknown
The purpose of this study is to evaluate the safety, tolerance, and immunogenicity of MAS-1-Adjuvanted seasonal inactivated influenza vaccine (IIV) (MER4101) with hemagglutinin dose escalation compared to non-adjuvanted comparator IIV standard dose (SD) in healthy adults and high dose (HD) IIV in ambulatory elderly subjects. Hypothesis: Reduced HA dose IIV formulated in MAS-1 adjuvant (MER4101) has been shown under Phase 1A to be safe, tolerable and demonstrated a more robust and durable immune... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
09/04/2019
Locations: Saint Louis University School of Medicine, Saint Louis, Missouri
Conditions: Influenza, Human
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Completed
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine... Read More
Gender:
ALL
Ages:
Between 18 years and 45 years
Trial Updated:
05/21/2019
Locations: Investigational Site 003, Springfield, Missouri
Conditions: Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Completed
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Gender:
ALL
Ages:
Between 40 years and 70 years
Trial Updated:
03/18/2019
Locations: Not set, Kansas City, Missouri +1 locations
Conditions: Healthy