Phase 3 N=68 Group B Streptococcus Response After Probiotic Exposure
Group B Strep Infection
Primary: GBS Culture Result (Positive Versus Negative) — 3; 6; 18; 19 Participants
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Phase 2 N=75 Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
GBS Disease · Streptococcus Agalactiae
Primary: Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age — 6.98; 0.24; 6.18; 0.39 µg/mL
N/A N=251 Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
Infection · Pregnancy
Primary: Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age — 20; 23 Participants — p=0.87
Phase 2 N=172 Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
Streptococcal Infection · Gram-positive Bacterial Infection · Bacterial Infection
Primary: Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth — 5.39; 0.41; 4.37; 0.4 µg/mL
Phase 1 N=240 Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Infection by Streptococcus Group B
Primary: Part A Number of Participants With Treatment Emergent Adverse Events — 6; 5; 5; 6 participants
Phase 2 N=667 Prevention of GBS Colonization Via Immunity
Beta Haemolytic Streptococcal Infection
Primary: The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture…
Phase 1 N=60 Group B Streptococcus Vaccine in Healthy Females
Group B Strep Infection
Primary: Number of Participants With Treatment Emergent Adverse Events — 17; 15; 8 Participants
Phase 1 N=678 Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Group B Streptococcus
Primary: Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 — 38; 30; 30; 29 percentage of subjects
N/A N=110 Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women
Group B Streptococcal Infection
Primary: Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth — 21; 9 Participants
Phase 2 N=66 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
Group B Streptococcus Infections
Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1 — 27.3; 27.3; 13.6; 22.7 Percentage of…
Phase 2 N=697 Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Streptococcal Infections
Primary: The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. — 91; 37; 91; 32 percentage of…
Phase 2 N=365 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
Group B Streptococcal Infections
Primary: Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade — 0; 6.3; 12.5; 0…
Phase 2 N=306 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
Group B Streptococcus Infections
Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination — 39.2; 45.9; 33.0; 27.5 Percentage of participants
Phase 2 N=1,050 Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
Infections, Streptococcal · Streptococcal Infections
Primary: Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women — 6.81; 6.66 µg/mL
Phase 2 N=98 Antibiotic "Dysbiosis" in Preterm Infants
Enterocolitis, Necrotizing · Bacteremia · Bronchopulmonary Dysplasia
Primary: Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death…
Phase 1 N=90 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
Group B Streptococcal Infections
Primary: Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine — 23; 21; 5; 10 Participants
N/A N=771 Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
Streptococcus Agalactiae Infection
Primary: Performance Characteristics — 95.9; 95.5 percentage of specimens
Phase 3 N=1,184 Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Infections, Meningococcal
Primary: Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1 — 156; 100; 39; 25 Participants
Phase 3 N=1,579 Safety and Efficacy of Pagibaximab Injection in Very Low Birth Weight Neonates for Prevention of Staphylococcal Sepsis
Staphylococcal Sepsis
Primary: The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35. — 85; 79 Participants
Phase 4 N=60 Management of Sub-Clinical Bacteriuria in Pregnancy
Cystitis · Cystitis;Puerperium · Pyelonephritis
Primary: Number of Participants Who Have Cystitis — 4; 4 Participants
Phase 2 N=134 Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Feeding; Difficult, Newborn · Growth Failure · Necrotizing Enterocolitis
Primary: Time to Establish Full Enteral Feeds — 15; 15 days
Phase 2 N=149 Early Versus Delayed BCG Vaccination of HIV-exposed Infants
HIV Exposure · HIV Infection
Primary: T Cell Activation — 1.8; 1.3 percentage of CD4+ T cells
Phase 2 N=269 Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
Group B Streptococcal Infection
Primary: Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby — 11.12; 5.52; 7.95; 3.51 μg/mL
Phase 2 N=30 Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Cystic Fibrosis · Bronchiectasis Adult · Non-Tuberculous Mycobacteria
Primary: BCG Uptake — 48.06; 0.84; 35.97 spot forming units
N/A N=24 Probiotics in Infants With Gastroschisis
Gastroschisis
Primary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01
Phase 1 N=60 Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Healthy Volunteer
Primary: Safety of Serum Derived Bovine Immunoglobulins (BSIgG) — 1; 2; 0; 2 Participants
Phase 2 N=370 Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Postoperative Urinary Tract Infection · Pelvic Organ Prolapse · Stress Urinary Incontinence
Primary: Post-operative Urinary Tract Infection — 19; 20 Participants
Phase 3 N=207 Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
Acinetobacter Baumannii-calcoaceticus Complex · Hospital-acquired Bacterial Pneumonia · Ventilator-associated Bacterial Pneumonia
Primary: Proportion of Patients With All-Cause Mortality in CRABC m-MITT Population — 12; 20 Participants
N/A N=700 Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients
Urinary Tract Infection · Infection Due to ESBL Bacteria · Environmental Contamination of ESBL
Primary: Treatment Failure — 23; 101 Treatment success
N/A N=2 Safety of 4CMenB Exposure During Pregnancy
Infections, Meningococcal
Primary: Major Congenital Malformation (MCM)