Clinical trials: Gram-negative Bacterial Infections
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
Pertussis (Whooping Cough), Tetanus
Safety Monitoring of Boostagen® Vaccine in Thailand
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
- Conditions
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Trial name
- BOOSTg001 (NCT07444502)
- Where
- Thailand
- Volunteers
- 10,727 people, healthy volunteers welcome
- Sponsor
- BioNet-Asia Co., Ltd.
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
Diphtheria, Tetanus
Database Surveillance Safety Study of PENTACEL® Vaccine
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae
- Trial name
- NCT00804284
- Testing
- DTaP-IPV/Hib, Other DTap Vaccines
- Where
- United States
- Volunteers
- 62,538 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months
The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.
- Trial name
- NCT05252715
- Testing
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine, Meningococcal A and C Polysaccharide Conjugate Vaccine
- Where
- 2 sites in China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Tetanus, Diphtheria
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
Primary objective: To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT02274285
- Testing
- DTaP-IPV/Hib Combined vaccine, DTaP-IPV vaccine and Hib vaccine
- Where
- 12 sites in Japan
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Diphtheria, Tetanus
Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older
Primary objective: To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Pertussis
- Trial name
- NCT01287949
- Testing
- Diphtheria, tetanus, polio and pertussis vaccination
- Where
- 12 sites in France, Germany
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Acellular Pertussis, Tetanus
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
- Trial name
- NCT00376779
- Testing
- Infanrix hexa Vaccine
- Where
- 6 sites in Finland
- Volunteers
- 450 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.
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
Chlamydia, Gonorrhea
Detection of Chlamydia (CT) and Gonorrhea (NG)
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken…
- Trial name
- NCT02055742
- Testing
- illumigene CT and NG assays, illumipro-10
- Where
- 3 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
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
Chlamydial Infections
Validation of Chlamydia Diagnostic Codes in TriNetX US EHR Data
This study is a pharmacoepidemiologic method study based on the secondary use of pre-existing data that examines whether TriNetX, a global health research network encompassing a worldwide electronic health record (EHR), database…
- Trial name
- NCT07094373
- Where
- United States
- Volunteers
- 4,878,935 people
- Sponsor
- Sanofi
Shiga Toxin Producing Bacterial Infection
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.
- Trial name
- NCT01252199
- Testing
- cαStx1/cαStx2
- Where
- 11 sites in Argentina, Chile and 1 more
- Volunteers
- 45 people
- Sponsor
- Thallion Pharmaceuticals