Clinical trials: Group B Streptococcus
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
Group B Streptococcus, Sepsis
Management of Infants Born to Group B Streptococcus Positive Mothers.
Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset neonatal sepsis caused by GBS. According to current recommendations, the evaluation of infants at risk for GBS sepsis should include a…
- Conditions
- Group B Streptococcus, Sepsis, Infant, Newborn
- Trial name
- NCT00716781
- Volunteers
- 16,394 people
- Sponsor
- IRCCS Burlo Garofolo
Invasive Streptococcal Infection, Invasive Group A Streptococcal Disease
Genetic Susceptibility to Severe Streptococcal Infections
Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia, meningitis and others.
- Conditions
- Invasive Streptococcal Infection, Invasive Group A Streptococcal Disease, Invasive Group B Streptococcal Disease, Necrotising Fasciitis
- Trial name
- NCT01911572
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Streptococcus Agalactiae (Streptococcus Group B)
The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast
Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide. Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal sepsis (EOS, in <7 days of life) in sSA.
- Trial name
- GBS (NCT01757041)
- Where
- 4 sites in Kenya
- Volunteers
- 7,967 people
- Sponsor
- University of Oxford
Group B Streptococcus Infections
Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various…
- Trial name
- NCT03765073
- Testing
- Multivalent Group B streptococcus vaccine
- Where
- 35 sites in United States, South Africa and 1 more
- Volunteers
- 1,208 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Invasive Group B Streptococcus Disease, Group B Streptococcus
Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
The goal of this registry is to collect and store important medical and non-health information on children from 0 to 18 years of age affected by early- (up to 24 hours after birth) and late-onset (up to 90 days after birth)…
- Conditions
- Invasive Group B Streptococcus Disease, Group B Streptococcus, Group B Streptococcal Infection, Group B Streptococcus (GBS) Disease
- Trial name
- COMPPASS (NCT06896526)
- Volunteers
- 10,000 people
- Sponsor
- Precia Group
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
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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 Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period.
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- ProGreSs (NCT04549220)
- Where
- Uganda
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Dengue, Chikungunya
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics.
- Conditions
- Dengue, Chikungunya, Zika Virus Infection, Japanese Encephalitis
- Trial name
- RACSMEI (NCT07358910)
- Where
- Cambodia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur du Cambodge
Group B Streptococcal Infection
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women.
- Trial name
- NCT05154578
- Testing
- GBS-NN/NN2 Vaccine
- Where
- 10 sites in Denmark, South Africa and 1 more
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serocorrelate of Protection Against GBS (PREPARE WP3)
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- NCT04732026
- Where
- 6 sites in France, Italy and 4 more
- Volunteers
- 600 people
- Sponsor
- St George's, University of London
Invasive Group B Streptococcal Disease
Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China
Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data.
- Trial name
- NCT02812576
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Xi'an Jiaotong University
Invasive Group B Streptococcal Disease
Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China
Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution
- Trial name
- NCT01933646
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- Novartis Vaccines