Clinical trials: Gram-Negative Bacterial Infections
Diphtheria, Hepatitis B
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT02853929
- Testing
- Infanrix hexa
- Where
- 29 sites in Australia, Canada and 4 more
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infection, Meningococcal
Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine
- Trial name
- NCT04714229
- Testing
- Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine, Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Hepatitis B, Pertussis
Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)
This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old…
- Trial name
- NCT02759354
- Testing
- Blood Sample
- Volunteers
- 754 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Lyme Disease
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe.
- Trial name
- VALOR (NCT05477524)
- Testing
- VLA15, Saline
- Where
- 129 sites in United States, Canada and 5 more
- Volunteers
- 12,546 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Pseudomonas Aeruginosa Infection
Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation…
- Trial name
- NCT01563263
- Testing
- IC43
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 803 people
- Sponsor
- Valneva Austria GmbH
Epidemic Meningitis, Meningococcal Vaccines
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.
- Trial name
- NCT07505836
- Testing
- experimental vaccine, Active Comparator vaccine
- Where
- 2 sites in China
- Volunteers
- 1,040 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Pressure Ulcer
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.
- Trial name
- NCT04815798
- Testing
- Bacteriophage-loaded Microcapsule Spray, Standard of Care
- Volunteers
- 69 people
- Sponsor
- Precisio Biotix Therapeutics, Inc.
Plague Vaccine
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts.
- Trial name
- NCT01122784
- Testing
- rF1V vaccine (with Adjuvant), rF1V vaccine (without Adjuvant)
- Where
- 11 sites in United States
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Lyme Borreliosis, Nervous System
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without…
- Trial name
- NCT03010228
- Testing
- VLA15 with Alum, VLA15 without Alum
- Where
- 5 sites in United States, Belgium
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pneumonia - Bacterial, Pseudomonas Aeruginosa Infection
MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia.
- Trial name
- MP101-1001 (NCT07492771)
- Testing
- MP101, Antibiotics
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- MicrobiotiX Co., Ltd
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis, Whooping Cough
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose…
- Trial name
- NCT03942406
- Testing
- BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Melioidosis
An Observational Study to Evaluate Clinical Characteristics of Adult Patients With Suspected or Confirmed Melioidosis
This is a prospective observational study to evaluate clinical characteristics, current practice and outcomes of adult patients (age ≥18 years) with suspected or confirmed melioidosis.
- Trial name
- NCT06089668
- Testing
- Observational Study
- Where
- 3 sites in Laos, Thailand
- Volunteers
- 200 people
- Sponsor
- AN2 Therapeutics, Inc
Meningococcal
A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays
The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay…
- Trial name
- NCT02072525
- Testing
- Menveo®, Boostrix®, Pneumovax 23®
- Where
- Canada
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gram-Negative Bacterial Infections
Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms
To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae…
- Trial name
- NCT00079989
- Testing
- tigecycline
- Volunteers
- 115 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Meningitis, Meningococcal, Serogroup B
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the…
- Trial name
- NCT02305446
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine
- Where
- Poland
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningococcal Infections
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
- Trial name
- NCT00626327
- Testing
- MenACWY-CRM + MMRV, MMRV, MenACWY-CRM
- Where
- 90 sites in United States
- Volunteers
- 1,630 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Cystic Fibrosis, CF
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
- Conditions
- Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- NCT01055847
- Testing
- Aztreonam for Inhalation (AI)
- Where
- 20 sites in United States
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences