Clinical trials: Gram-negative Bacterial Infection
Hepatitis B, Acellular Pertussis
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month…
- Conditions
- Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria
- Trial name
- NCT01457560
- Testing
- DTPa-HBV-IPV/Hib (Infanrix hexa™), OPV
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lyme Disease
Lyme Test Indication Combinations (LyTIC) Study
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
- Trial name
- LyTIC (NCT03201042)
- Testing
- PCR based assay, Serology based assay, Tcell based assay
- Where
- 60 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Oxford Immunotec
Meningitis, Meningococcemia
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
- Trial name
- NCT00777790
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 9 sites in United States
- Volunteers
- 241 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules
The proposed study is aimed to assess the antibody response and short-term persistence of Novartis Meningococcal B Vaccine after one, two or three doses and to evaluate the optimal vaccination schedule in an adolescent population.
- Trial name
- NCT00661713
- Testing
- rMenB+OMV NZ
- Where
- 10 sites in Chile
- Volunteers
- 1,631 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi
Meningitis, Meningococcal
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months
- Trial name
- NCT02878291
- Testing
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in…
- Trial name
- EPIC (NCT02486627)
- Testing
- plazomicin, meropenem, levofloxacin (oral)
- Volunteers
- 609 people
- Sponsor
- Achaogen, Inc.
Meningococcal Disease
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged…
- Trial name
- NCT01973218
- Testing
- Meningococcal B Recombinant vaccine rMenB+OMV NZ, Meningococcal ACWY-CRM conjugate vaccine
- Where
- 7 sites in South Korea
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal Meningitis
Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT01519713
- Testing
- Meningococcal polysaccharide diphtheria toxoid conjugate
- Where
- 3 sites in Japan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT)…
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Trial name
- NCT06369220
- Testing
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Where
- 4 sites in United States
- Volunteers
- 331 people
- Sponsor
- Hoffmann-La Roche
Pertussis, Tetanus
Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose
The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against…
- Conditions
- Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00712959
- Testing
- Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis (ADACEL®)
- Where
- 7 sites in Canada
- Volunteers
- 769 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease, Meningococcal Meningitis
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.
- Trial name
- NCT01434680
- Testing
- MenC-CRM LIQ, MenC-CRM ROS, MenC-CRM EMV
- Where
- 11 sites in Poland
- Volunteers
- 992 people, healthy volunteers welcome
- Sponsor
- Novartis
Diarrheal Disease, Infectious, Gastrointestinal Disease
Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
- Conditions
- Diarrheal Disease, Infectious, Gastrointestinal Disease, Reactive Arthritis
- Trial name
- NCT05409196
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Hungary
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline