Clinical trials: Gram-Negative Bacterial Infections
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Haemophilus Influenzae Type b Infections
Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried
The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine.
- Trial name
- NCT02560272
- Testing
- Minhai-HIB, Act-HIB®
- Where
- China
- Volunteers
- 1,560 people, healthy volunteers welcome
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd
Viral Hepatitis Vaccines, Hepatitis A
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus
- Trial name
- NCT01160081
- Testing
- Serum sample
- Where
- Mexico
- Volunteers
- 3,658 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
This study will evaluate the safety and immune response to GlaxoSmithKline Tdap vaccine compared to licensed Td vaccine when used as a booster in healthy adolescents (10-18 years of age).
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00109330
- Testing
- Combined diphtheria, tetanus, acellular pertussis vaccine
- Where
- 44 sites in United States
- Volunteers
- 4,116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infections, Meningitis
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
- Trial name
- NCT00862277
- Testing
- Menactra®, Menomune®
- Where
- 20 sites in United States
- Volunteers
- 763 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diarrhea
ETEC Logistics Trial (TREK)
This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
- Trial name
- Trek (NCT00516659)
- Testing
- Heat-Labile Enterotoxin of Escherichia coli (LT)
- Where
- 19 sites in United States, Guatemala and 1 more
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Meningococcal Infection, Healthy Volunteers
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and…
- Trial name
- NCT07135986
- Testing
- MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine, MenAC conjugate vaccine
- Where
- 4 sites in China
- Volunteers
- 1,602 people, healthy volunteers welcome
- Sponsor
- Sanofi
Pertussis
Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine
To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
- Trial name
- NCT00258882
- Testing
- Tetanus Toxoid, acellular pertussis, diphtheria toxoid
- Where
- 3 sites in United States
- Volunteers
- 327,293 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine…
- Trial name
- NCT03632720
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine, Meningococcal group B vaccine, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
- Where
- 13 sites in United Kingdom
- Volunteers
- 788 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
- Trial name
- NCT00950612
- Testing
- GSK's investigational vaccine 692342
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.
- Trial name
- NCT01210885
- Testing
- Meningococcal Vaccine
- Where
- 8 sites in Chile, Colombia and 1 more
- Volunteers
- 495 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused…
- Trial name
- NCT05082285
- Testing
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine
- Where
- 33 sites in Dominican Republic, Finland and 6 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Infection
Dose Comparison Study of Menactra® in US Children
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
- Conditions
- Meningitis, Meningococcal Infection, Neisseria Meningitidis
- Trial name
- NCT00700635
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
- Where
- 15 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Urinary Tract Infections
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the…
- Trial name
- ELIMINATE (NCT05488340)
- Testing
- LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose, LBP-EC01 IV Infusion Dose
- Where
- 17 sites in United States
- Volunteers
- 318 people
- Sponsor
- Locus Biosciences
Meningitis, Meningococcal Infection
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose.
- Trial name
- NCT01689155
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Haemophilus Influenzae Type b, Tetanus
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
The purpose of the study is as follows: To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study…
- Conditions
- Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis, Hepatitis B
- Trial name
- NCT00317174
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- Philippines
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumonia, Ventilator Associated Pneumonia
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of…
- Trial name
- NCT00851435
- Testing
- KBPA-101
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Kenta Biotech Ltd
Cystic Fibrosis, Burkholderia Infection
A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection
The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
- Trial name
- SMR-2591 (NCT02453789)
- Testing
- Alginate oligosaccharide
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- AlgiPharma AS