Clinical trials: Streptococcus Agalactiae Infection
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
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 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 Infection
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women…
- Trial name
- NCT04596878
- Testing
- GBS-NN/NN2
- Where
- 3 sites in South Africa, Uganda
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcus Infection
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of…
- Trial name
- NCT05005247
- Testing
- GBS-NN/NN2
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Strep Infection
Group B Streptococcus Vaccine in Healthy Females
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
- Trial name
- MVX0002 (NCT03807245)
- Testing
- GBS-NN/NN2 with Alhydrogel® 25, GBS-NN/NN2 with Alhydrogel® 50
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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
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
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
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.
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
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
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
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B…
- Trial name
- NCT05782179
- Testing
- GBS-NN/NN2
- Where
- Belgium
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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 Streptococcal Infection
Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women
The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in…
- Trial name
- NCT01577108
- Testing
- Probiotic
- Where
- Taiwan
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital