Clinical trials: Gram-Negative Bacterial Infections
Infections, Meningococcal
Safety of 4CMenB Exposure During Pregnancy
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age.
- Trial name
- NCT02640677
- Testing
- 4CMenB
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Pertussis/Whooping Cough, Bordetella Pertussis, Whooping Cough
Pertussis Challenge Study in Adults Vaccinated With BPZE1
This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
- Trial name
- CHAMPION-1 (NCT05461131)
- Testing
- BPZE1, Azithromycin, Bordetella Pertussis Challenge Strain
- Where
- 2 sites in United Kingdom
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Tetanus, Diphtheria
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this…
- Conditions
- Tetanus, Diphtheria, Pertussis
- Trial name
- NCT00467519
- Testing
- Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis), DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
- Where
- 43 sites in United States, Canada
- Volunteers
- 1,045 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Syphilis
Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® Syphilis Screen and Confirm rapid test.
- Trial name
- NCT01543295
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Chembio Diagnostic Systems, Inc.
Syphilis Infection, Treponema Pallidum Infection
NOWDx Test for the Diagnosis of Syphilis
This study is designed to compare the performance of the NOWDx Syphilis Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device.
- Trial name
- NCT05063344
- Testing
- Diagnostic Test: NOWDx Syphilis Test
- Where
- 6 sites in United States
- Volunteers
- 1,535 people
- Sponsor
- NOWDiagnostics, Inc.
Infections, Meningococcal, Meningococcal Vaccines
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
- Trial name
- NCT00514904
- Testing
- Nimenrix, Mencevax
- Where
- 7 sites in India, Lebanon and 2 more
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
A Study to Learn About the Safety of PENBRAYA During Pregnancy
This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the…
- Trial name
- NCT07768163
- Testing
- PENBRAYA
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pfizer
Immunization; Infection
Phase 3 Study of BK1310 in Healthy Infants
The purpose of this study is to: (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy…
- Trial name
- NCT02992925
- Testing
- DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine）, Hib vaccine
- Where
- 3 sites in Japan
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Pertussis Vaccines, Pertussis (Whooping Cough)
Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received…
- Trial name
- NCT06888076
- Where
- Thailand
- Volunteers
- 2,700 people, healthy volunteers welcome
- Sponsor
- BioNet-Asia Co., Ltd.
Chlamydia Infections, Gonorrhea
Prospective Collection of Female and Male Specimens for PANTHER® System Testing
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System
- Trial name
- NCT01638637
- Testing
- APTIMA Assays; PANTHER System
- Where
- 16 sites in United States
- Volunteers
- 1,492 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
Increased Lordosis/Scoliosis, Hyporeflexia
Biomarker for Duchenne Muscular Dystrophy
International, multicenter, observational, longitudinal study to identify biomarker/s for Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.
- Conditions
- Increased Lordosis/Scoliosis, Hyporeflexia, Duchenne Muscular Dystrophy, Red-Green Color Blindness
- Trial name
- BioDuchenne (NCT02994030)
- Where
- 12 sites in Albania, Egypt and 6 more
- Volunteers
- 103 people
- Sponsor
- CENTOGENE GmbH Rostock
Cholera (Disorder)
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.
- Trial name
- NCT03220737
- Testing
- VAXCHORA (Cholera Vaccine, Live, Oral)
- Where
- 10 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Diphtheria, Tetanus
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: To demonstrate that ACTACEL vaccine administered at 2, 3 and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type B
- Trial name
- NCT01062477
- Testing
- DTaP//PRP-T Combined Vaccine, DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
- Where
- 2 sites in China
- Volunteers
- 1,056 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diphtheria, Tetanus
A Study to Assess the Safety of Adacel® Vaccine
The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01040052
- Testing
- Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)
- Where
- Vietnam
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00258895
- Testing
- DAPTACEL®: DTaP
- Where
- 22 sites in United States
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Prevention Harmful Effects
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
- Trial name
- OCV (NCT01707537)
- Testing
- Euvichol
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Whooping Cough, Diphtheria
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will…
- Conditions
- Whooping Cough, Diphtheria, Tetanus
- Trial name
- DTaP (NCT05091619)
- Testing
- Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed, Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
- Where
- 4 sites in China
- Volunteers
- 2,898 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
Cystic Fibrosis
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
- Trial name
- NCT00638365
- Testing
- KB001
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Humanigen, Inc.
Pseudomonas Aeruginosa Pneumonia
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
- Trial name
- NCT03027609
- Testing
- AR-105
- Where
- 111 sites in United States, Australia and 15 more
- Volunteers
- 158 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
Meningococcal Disease
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY…
- Trial name
- NCT01345721
- Testing
- MenACWY-CRM
- Where
- 11 sites in Germany
- Volunteers
- 205 people
- Sponsor
- Novartis Vaccines