Clinical trials: Gram-negative Bacterial Infections
- Condition Gram-negative Bacterial Infections
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the…
- Trial name
- NCT02212457
- Testing
- Bexsero, Havrix, MenABCWY
- Where
- 32 sites in United States, Finland and 1 more
- Volunteers
- 1,063 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Helicobacter Pylori Infection
Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori
At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in…
- Trial name
- NCT01109381
- Testing
- GT08
- Where
- Singapore
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Synergy Pharmaceuticals Pte. Ltd.
Diphtheria, Tetanus
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT00303316
- Testing
- DTaP-IPV//PRP~T combined vaccine
- Where
- Argentina
- Volunteers
- 458 people, healthy volunteers welcome
- Sponsor
- Sanofi
Infections, Meningococcal
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months.
- Trial name
- NCT01939158
- Testing
- Meningococcal vaccine GSK134612, Prevenar 13™
- Where
- 51 sites in Australia, Canada and 4 more
- Volunteers
- 803 people, healthy volunteers welcome
- Sponsor
- Pfizer
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, Diphtheria
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.
- Conditions
- Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT00325143
- Testing
- DTPa-HBV-IPV/Hib, DTPa-IPV/Hib vaccine
- Where
- 3 sites in Singapore
- Volunteers
- 702 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumonia, Bacterial
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and…
- Trial name
- INHALE 1 (NCT01799993)
- Testing
- Amikacin Inhalation Solution (BAY41-6551)
- Where
- 65 sites in United States, Australia and 10 more
- Volunteers
- 725 people
- Sponsor
- Bayer
Meningococcal Disease, Meningococcal Meningitis
Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10
This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).
- Trial name
- NCT01148524
- Testing
- No Vaccine, rMenB+OMV-NZ
- Where
- 6 sites in Chile
- Volunteers
- 817 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Tetanus, Diphtheria
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine.
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Trial name
- NCT01439165
- Testing
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
- Where
- 33 sites in United States, Canada
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a…
- Trial name
- NCT01823536
- Testing
- Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
- Where
- 16 sites in United States, Ukraine
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
- Trial name
- NCT01123941
- Testing
- Typherix, NVGH Vi-CRM197
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis
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
Pulmonary Infections, Pseudomonas Aeruginosa
Second Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were…
- Trial name
- NCT01069705
- Testing
- Tobramycin inhalation powder
- Where
- 17 sites in Bulgaria, Estonia and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Diphtheria, Tetanus
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
- Trial name
- NCT00325156
- Testing
- GSK Biologicals' combined DTPa-IPV/Hib vaccine
- Where
- Singapore
- Volunteers
- 2,590 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lyme Borreliosis
Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase.
- Trial name
- NCT03769194
- Testing
- VLA15
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 572 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infections, Meningococcal
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single…
- Trial name
- NCT02986854
- Testing
- Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 704 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
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
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company