Clinical trials: Gram-negative Bacterial Infection
Meningococcal Meningitis, Meningococcal Infections
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
- Trial name
- NCT00937521
- Testing
- Meningococcal B vaccine, Control, Meningococcal B vaccine with antipyretic
- Where
- 38 sites in Argentina, Chile and 3 more
- Volunteers
- 1,507 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Meningitis, Meningococcal Infections
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.
- Trial name
- NCT00474487
- Testing
- Meningococcal ACWY Polysaccharide Vaccine, MenACWY CRM (19 to 55 years), Meningococcal ACWY Conjugate Vaccine
- Where
- 2 sites in Argentina, Colombia
- Volunteers
- 2,831 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
Dysentery, Dysentery, Bacillary
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
- Trial name
- NCT04865497
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b Conjugate Vaccine
- Where
- China
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Dysentery, Shigellosis
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
- Trial name
- NCT05156528
- Testing
- S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
- Where
- 9 sites in China
- Volunteers
- 21,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Meningitis, Meningococcal
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease…
- Trial name
- NCT05087056
- Testing
- MenABCWY vaccine
- Where
- 30 sites in United States, Germany
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study…
- Trial name
- NCT00715910
- Testing
- Nimenrix, Blood sampling
- Where
- 10 sites in United States
- Volunteers
- 818 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhea
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD)…
- Trial name
- NCT00328380
- Testing
- Rifaximin
- Where
- 3 sites in United States
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Pertussis, Diphtheria
Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available…
- Conditions
- Pertussis, Diphtheria, Poliomyelitis, Tetanus
- Trial name
- NCT00319852
- Testing
- DTaP-IPV combined vaccine, DTaP vaccine
- Where
- South Korea
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Sanofi
Pertussis
Boostrix® Pregnancy Registry
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US.
- Trial name
- NCT02096276
- Testing
- Data collection
- Where
- United States
- Volunteers
- 1,517 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bronchiectasis
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas…
- Trial name
- NCT00775138
- Testing
- 280 mg Arikayce™, 560 mg Arikayce™
- Where
- 18 sites in United States, Bulgaria and 7 more
- Volunteers
- 64 people
- Sponsor
- Insmed Incorporated
Infections, Streptococcal, Streptococcus Pneumoniae
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously…
- Trial name
- NCT00907777
- Testing
- Pneumococcal conjugate vaccine GSK 1024850A, Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
- Where
- 17 sites in Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who…
- Trial name
- NCT02382913
- Testing
- aP booster, TdaP booster, Licensed TdaP booster (Boostrix®)
- Where
- Belgium
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Novartis
Epidemic Meningitis
Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660…
- Trial name
- NCT05935176
- Testing
- MCV4
- Where
- China
- Volunteers
- 660 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Infections, Meningococcal
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®)…
- Trial name
- NCT00614614
- Testing
- GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix), Infanrix®
- Where
- 56 sites in United States
- Volunteers
- 1,558 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and…
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections
- Trial name
- NCT07708116
- Testing
- CTX-187
- Where
- Netherlands
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Centauri Therapeutics Limited
Dysentery, Dysentery, Shigella
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years.
- Trial name
- NCT06838195
- Testing
- S. Flexneri-S. Sonnei bivalent conjugate vaccine
- Where
- Bangladesh
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease, Meningococcal Meningitis
Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
- Trial name
- NCT01214837
- Testing
- MenACWY-CRM, Routine Vaccines
- Where
- 40 sites in United States, Canada
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines