Clinical trials: Group B Streptococcal Infection
Group B Streptococcus
Group B Streptococcus (GBS) Polymerase Chain Reaction (PCR) Concordance Study
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus.
- Trial name
- NCT00972894
- Where
- 2 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- HCA International Limited
Streptococcus Agalactiae Infection
GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration…
- Trial name
- NCT06494475
- Testing
- GBS-NN/NN2 vaccine, Tdap vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Preparing for Maternal GBS Vaccine Trials in Africa
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
- Conditions
- Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
- Trial name
- PROTECT (NCT06833957)
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 18,100 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
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.
Preterm Labor
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART. 221 subjects will be involved.
- Trial name
- NCT03122704
- Testing
- GBS screening
- Where
- Vietnam
- Sponsor
- Manh Tuong Ho
Premature Rupture of Fetal Membranes, Group B Streptococcal Infection
Group B Streptococcus Infection and PROM Incidince
To investigate incidince of prom with GBS infection and role of prophylaxis against it
- Trial name
- NCT06735703
- Testing
- To provide ampicillin sulbactam to pregnant women with premature rupture of membrane
- Volunteers
- 150 people
- Sponsor
- Assiut University
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Neonatal Sepsis
Neonatal Sepsis and GBS Carriage Study
In the proposed study, the investigators plan to establish the burden of early onset (EO) neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period. Aims 1.
- Trial name
- NSS (NCT00861055)
- Where
- Thailand
- Volunteers
- 849 people
- Sponsor
- University of Oxford
Group B Streptococcal Infection, Infection Due to ESBL Bacteria
Simplified GBS Screening and Prevalence of ESBL in Pregnant Women
1. At the University Hospital Basel, Switzerland, a simplified screening for group B streptococci (GBS) of vagina and perineum has been performed since several years.
- Trial name
- NCT02142933
- Testing
- vagino-perineal swab
- Where
- Switzerland
- Volunteers
- 250 people
- Sponsor
- University Hospital, Basel, Switzerland
Invasive Infection, Diabetic Foot
Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.
Group B Streptococcus (GBS) infection is a potential aetiology of meningitis and septicemia in neonates, pregnant women and non-pregnant adults.
- Conditions
- Invasive Infection, Diabetic Foot, Immunocompromised Patients, Group B Streptococcal Infections
- Trial name
- NCT05726006
- Testing
- No Intervention in This study
- Where
- Malaysia
- Volunteers
- 133 people
- Sponsor
- Universiti Putra Malaysia
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
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
Streptococcus Pyogenes Pharyngitis, Streptococcus Pharyngitis
Controlled Human Infection for Vaccination Against Streptococcus Pyogenes
Group A Streptococcus (GAS) infection is a major cause of death and disability globally with a disproportionately high burden in settings of disadvantage worldwide.
- Conditions
- Streptococcus Pyogenes Pharyngitis, Streptococcus Pharyngitis, Strep Throat, Streptococcus Pyogenes Infection
- Trial name
- CHIVAS (NCT03361163)
- Testing
- emm75 Streptococcus pyogenes (GAS M75, strain 611024)
- Where
- Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Andrew Steer
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 Infection, Pregnancy
Rapid Diagnostic Test for Detection of Group B Streptococcus in Pregnancy
This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6…
- Trial name
- GBS (NCT01445717)
- Where
- United States
- Volunteers
- 358 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Maternal Health, Child Health
Group B Strep Correlates of Protection Study
Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries.
- Conditions
- Maternal Health, Child Health, Infectious Diseases
- Trial name
- GBSCoP (NCT06431217)
- Where
- South Africa
- Volunteers
- 17,842 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Streptococcus Agalactiae Infection
Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease
A multicentre study to provide evidence that the relationship between an immune marker value (anti-GBS IgG concentration) and the probability of invasive GBS (iGBS) disease in infants less than 90 days of age is sufficiently…
- Trial name
- iGBS3 (NCT04735419)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- St George's, University of London
Beta Haemolytic Streptococcal Infection
Prevention of GBS Colonization Via Immunity
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina.
- Trial name
- NCT00128219
- Testing
- GBS III-TT, Tetanus and diptheria toxoids vaccine
- Where
- 3 sites in United States
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Group B Strep Infection
mulTiplex Immunoassay qualiTy assuRance Panel
Collection of serum from women not living with HIV, who received the GBS6 vaccine in the "a placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human…
- Trial name
- TITRE (NCT07562061)
- Testing
- Collection of 50mls of blood
- Where
- Uganda
- Volunteers
- 50 people
- Sponsor
- St George's, University of London