Combination Study With MVA BN and Dryvax
Completed
The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. Participants will include 90 healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study groups (groups A-F). Participants will be involved in study related procedures for up to 2 years. During this time, volunteers will retur... Read More
Gender:
ALL
Ages:
Between 18 years and 32 years
Trial Updated:
12/18/2014
Locations: Saint Louis University, St. Louis, Missouri
Conditions: Smallpox
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
Completed
The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine. Researchers will also look at how the body reacts to the flu vaccine and how it affects the babies of pregnant women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60 non-pregnant women. Participants will b... Read More
Gender:
FEMALE
Ages:
Between 18 years and 39 years
Trial Updated:
12/04/2014
Locations: Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri
Conditions: Influenza
Comparison of Delivery Routes of Flu Vaccine in Adults
Completed
This protocol is to compare the immune response of different influenza vaccines given by two different routes of administration in healthy adults ages 18 to 64 years.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
12/04/2014
Locations: Saint Louis University, St. Louis, Missouri
Conditions: Influenza
Expanded Dryvax Dilution Study in Previously Vaccinated Adults
Completed
The purpose of this study is to determine the safety and effect of diluting smallpox vaccine, making a larger number of doses in case smallpox is released into the environment. A total of up to 927 healthy adults between the ages of 32 and 70 years who were already vaccinated against smallpox (but not since 1989) will volunteer for this study for up to 34 weeks and receive different strengths of vaccine. Some subjects may participate for longer if they choose to be revaccinated because the first... Read More
Gender:
ALL
Ages:
Between 32 years and 70 years
Trial Updated:
12/04/2014
Locations: Saint Louis University, St. Louis, Missouri
Conditions: Smallpox
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
Completed
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
06/27/2014
Locations: The Center for Pharmaceutical Research, P.C., Kansas City, Missouri +1 locations
Conditions: Influenza
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Completed
The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparati... Read More
Gender:
ALL
Ages:
65 years and above
Trial Updated:
06/16/2014
Locations: 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827, Saint Louis, Missouri +1 locations
Conditions: Influenza
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Completed
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
Gender:
ALL
Ages:
Between 55 days and 89 days
Trial Updated:
04/03/2014
Locations: 25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426, Kansas City, Missouri
Conditions: Meningococcal Disease
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Completed
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/06/2014
Locations: Not set, Springfield, Missouri
Conditions: Influenza, Swine-origin A/H1N1 Influenza
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Completed
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier. Primary Objective: To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in p... Read More
Gender:
ALL
Ages:
Between 3 years and 5 years
Trial Updated:
01/21/2014
Locations: Not set, Bridgeton, Missouri
Conditions: Meningitis, Meningococcemia, Neisseria Meningitidis
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Completed
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine... Read More
Gender:
ALL
Ages:
Between 7 years and 15 years
Trial Updated:
01/21/2014
Locations: Not set, Bridgeton, Missouri
Conditions: Meningitis, Meningococcal Infection
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Completed
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Gender:
ALL
Ages:
65 years and above
Trial Updated:
12/05/2013
Locations: Not set, Kansas City, Missouri +2 locations
Conditions: Influenza, Orthomyxovirus Infection, Myxovirus Infection
Study of Quadrivalent Influenza Vaccine Among Adults
Completed
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective: * To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
09/13/2013
Locations: Not set, Springfield, Missouri
Conditions: Influenza