Clinical trials: GBS
Infections, Streptococcal, Streptococcal Infections
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
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…
- Trial name
- NCT02270944
- Testing
- GBS Vaccine
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 1,053 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
Guillain-Barre Syndrome
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG)…
- Trial name
- NCT04752566
- Testing
- Eculizumab
- Where
- 22 sites in Japan
- Volunteers
- 57 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
GBS Disease, Streptococcus Agalactiae
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the…
- Trial name
- NCT02046148
- Testing
- GBS trivalent vaccine
- Where
- 6 sites in United States
- Volunteers
- 75 people
- Sponsor
- GlaxoSmithKline
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Guillain-Barré Syndrome (GBS)
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients.
- Trial name
- NCT03943589
- Testing
- Imlifidase
- Where
- 11 sites in France, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Hansa Biopharma AB
Streptococcal Infections
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
- Trial name
- NCT01193920
- Testing
- Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution, Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
- Where
- South Africa
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the…
- Trial name
- NCT02690181
- Testing
- GBS Trivalent Vaccine
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Group B Streptococcus
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
- Trial name
- NCT01150123
- Testing
- Group B streptococcus (GBS) vaccine- low dose, Group B streptococcus (GBS) vaccine- High dose
- Where
- Belgium
- Volunteers
- 678 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines