Clinical trials: Group B Streptococcus
Invasive Group B Streptococcus (GBS) Disease
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Trial name
- NCT00645346
- Testing
- GBS glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
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.
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
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
Streptococcus Agalactiae
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.
The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.
- Trial name
- NCT04165551
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 216 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Group B Streptococcus (GBS) Disease
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
- Trial name
- NCT01052935
- Testing
- Group B streptococcus (GBS) vaccine
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis
Gestational Mother, Streptococcus Agalactiae Infection
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B…
- Trial name
- PROBIGEST (NCT03669094)
- Testing
- Lactobacillus salivarius V4II-90
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
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
Invasive Group B Streptococcus Disease
Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not.
- Trial name
- NCT02099149
- Where
- South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis
Gestational Mother, Streptococcus Agalactiae Infection
Colonization with Group B Streptococcus During Pregnancy
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational.
- Trial name
- PROBIGEST (NCT03671486)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
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
Group B Streptococcus (GBS) Disease
A Study to Assess the Persistence of Two GBS Antibodies in Women Previously Immunized With a GBS Vaccine
This study looks at the body's immune response to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P2 study. Blood will be drawn and evaluated for GBS antibody levels.
- Trial name
- NCT01053767
- Testing
- Group B streptococcus (GBS) vaccine
- Where
- Switzerland
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Group B Streptococcal Infections
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a…
- Trial name
- NCT04258995
- Testing
- Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
- Where
- 4 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Pfizer
Group A Streptococcus: B Hemolytic Pharyngitis
Detection of GABHS in Throat Gargle
The objective of this study is to investigate the use of patient throat gargle as an alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic Streptococcus (GABHS) infection, also known as…
- Trial name
- NCT03231098
- Where
- Israel
- Volunteers
- 34 people
- Sponsor
- Gargle Tech
Group B Streptococcal Infections
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine.
- Trial name
- NCT03170609
- Testing
- Multivalent group B streptococcus vaccine
- Where
- 4 sites in United States
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Pfizer
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Pregnancy, GBS
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks…
- Trial name
- NCT02497430
- Where
- 5 sites in United States
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Luminex Corporation
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