Clinical trials: Group B Streptococcus
Group B Streptococcus (GBS) Colonization
Group B Streptococcus Colonization in Mother-newborn Dyads and Association With Serotype-specific Capsular Antibodies in Karachi, Pakistan.
Group B Streptococcus (GBS) of which there are 10 serotypes of varying invasive potential is a major cause of invasive bacterial disease in neonates and young infants.
- Trial name
- GBS (NCT05469256)
- Where
- Pakistan
- Volunteers
- 600 people
- Sponsor
- Aga Khan University
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 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.
Stillbirth
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths
- Trial name
- Stillborn (NCT02339077)
- Where
- 2 sites in South Africa
- Volunteers
- 354 people
- Sponsor
- University of Witwatersrand, South Africa
Neonatal Infections, Streptococcus Agalactiae
Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage: a Medico-Economic Study
Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area.
- Trial name
- BBFAST (NCT00920530)
- Where
- France
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
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
Group B Strep Infection
Group B Streptococcus Response After Probiotic Exposure
This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at…
- Trial name
- GRAPE (NCT04721912)
- Testing
- Probiotic dietary supplement
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of New Mexico
Genitourinary; Infection, Complicating Pregnancy
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries.
- Trial name
- NCT06231056
- Testing
- Probiotic iNatal®
- Where
- Italy
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Liaquat University of Medical & Health Sciences
GBS
The Implementation of Real-time PCR - Intrapartum GBS (Group B Streptococcus) Colonization to Reduce Antibiotic Prophylaxis
The implementation of real-time PCR for detection of intrapartum GBS (group B Streptococcus) colonization as a way to reduce antibiotic prophylaxis usage.
- Trial name
- NCT03936816
- Testing
- GBS vaginal double swab
- Where
- Israel
- Volunteers
- 303 people
- Sponsor
- Carmel Medical Center
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
Infection by Streptococcus Group B
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the…
- Trial name
- MVX13211 (NCT02459262)
- Testing
- GBS-NN vaccine
- Where
- United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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 Group B
Development and Optimization of a GBS Diagnostic Test
The purpose of this clinical study is to develop an easily performed test to detect Group B Streptococcus (GBS) in pregnant women at the time of delivery, which would allow health care providers to make an accurate and rapid…
- Trial name
- NCT00322829
- Where
- Canada
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Laval University
Streptococcus Agalactiae
CCA of SGB PCR Versus SGB Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis
Early-onset neonatal infection (EONI), occur within 7 days of birth. They are most often due to Streptococcus B (GBS) and are associated with heavy and costly morbidity and mortality.
- Trial name
- DEPIST2P (NCT05005169)
- Testing
- SGB PCR, SGB culture
- Where
- 11 sites in France
- Volunteers
- 3,321 people
- Sponsor
- Nantes University Hospital
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 a Monovalent 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
- NCT00657683
- Testing
- Monovalent GBS-CRM glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Group B Streptococcus
The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center
A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center
- Trial name
- NCT01251289
- Volunteers
- 628 people
- Sponsor
- Unity Health Toronto
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
Infection, Pregnancy
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal…
- Trial name
- NCT01479478
- Testing
- Probiotic dietary supplement
- Where
- 3 sites in United States
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Stanford University
Group B Streptococcus Infections
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with…
- Trial name
- NCT04766086
- Testing
- Multivalent Group B streptococcus vaccine, Tetanus, diphtheria, and acellular pertussis vaccine
- Where
- 12 sites in United States
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Pfizer