Clinical trials: Gram-negative Bacterial Infection
Uncomplicated Urogenital Gonorrhea
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea.
- Trial name
- SOLITAIRE-U (NCT02210325)
- Testing
- solithromycin, ceftriaxone, azithromycin
- Where
- 5 sites in United States, Australia
- Volunteers
- 264 people
- Sponsor
- Melinta Therapeutics, Inc.
Cystic Fibrosis
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
The purpose of this interventional Phase IV study was to explore the ease of use of TIP and prevalence of microbial contamination of the T-326 Inhaler compared with TIS and colistimethate administered via nebuliser for the…
- Trial name
- NCT01844778
- Testing
- Tobramycin Inhalation Powder, Tobramycin inhalation solution, Colistimethate
- Where
- 21 sites in Germany, Ireland and 3 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Diphtheria, Tetanus
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT00343421
- Testing
- PEDIACEL® and Prevenar®, Infanrix®-IPV+Hib and Prevenar®
- Where
- 2 sites in France, Poland
- Volunteers
- 588 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT01239043
- Testing
- Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide, Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 6 sites in United States
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Sanofi
Lyme Borreliosis
Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo.
- Trial name
- NCT03970733
- Testing
- VLA15
- Where
- 5 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Pfizer
Meningococcal Meningitis
Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
- Trial name
- NCT00310856
- Testing
- MenACWY-CRM, MenC-CRM, DTaP-Hib-IPV
- Where
- 3 sites in Canada
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Bordetella Pertussis, Whooping Cough
Pertussis Immunization Programs in Low Income Countries
Due to waning of infectious as well as vaccine immunity and lack of vaccination boosters, a large number of adolescents and adults are no longer immunized against Bordetella pertussis, the agent of whooping cough and consequently…
- Trial name
- PERILIC (NCT02983487)
- Testing
- Nasopharyngeal sampling, Blood Sampling
- Where
- 3 sites in Cambodia, Madagascar and 1 more
- Volunteers
- 3,587 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Salmonella Infections
A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults
The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa.
- Trial name
- NCT07663032
- Testing
- Pan-Salmonella-with-Alum (Low dose) vaccine, Pan-Salmonella-with-Alum (Full dose) vaccine, Pan-Salmonella-without-Alum (Low dose) vaccine
- Where
- South Africa
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HELICOBACTER INFECTION
Study of Pylopass Versus Placebo in Subjects Who Are Helicobacter Pylori Carriers and With Mild Indigestion
Helicobator pylori (H. pylori) is a bacteria which survives in the lining of the stomach. An estimated 50% of the world's population is infected with H. pylori.
- Trial name
- NCT02051348
- Testing
- Pylopass
- Where
- Ireland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Atlantia Food Clinical Trials
Diphtheria, Pertussis
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from…
- Conditions
- Diphtheria, Pertussis, Tetanus
- Trial name
- NCT01267058
- Testing
- GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine, Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00343889
- Testing
- DTaP-HB-PRP~T vaccine + OPV, Tritanrix-HepB/Hib™ + OPV vaccine, Oral Polio Vaccine
- Where
- 2 sites in Philippines
- Volunteers
- 379 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Pneumonic Plague, Preventive Therapy
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels.
- Trial name
- NCT00097396
- Testing
- rF1V vaccine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Diphtheria, Tetanus
Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT05457946
- Testing
- LBVD (Hexavalent vaccine), Pentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- LG Chem
Diphtheria-Tetanus-acellular Pertussis Vaccines
Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of…
- Trial name
- NCT03311659
- Testing
- Boostrix
- Where
- 8 sites in Russia
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacteremia Sepsis
Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K.
- Trial name
- PHENOTECH-1 (NCT05613322)
- Testing
- Resistell Phenotech
- Where
- 3 sites in Austria, Spain and 1 more
- Volunteers
- 246 people
- Sponsor
- Resistell AG
Meningitis, Meningococcemia
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.
- Conditions
- Meningitis, Meningococcemia, Pertussis, Tetanus
- Trial name
- NCT00777257
- Testing
- T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj., Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
- Where
- 20 sites in United States
- Volunteers
- 1,345 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease, Pregnancy
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to…
- Conditions
- Meningococcal Disease, Pregnancy, Infections, Meningococcal
- Trial name
- NCT02223637
- Testing
- Meningococcal quadrivalent CRM-197 conjugate vaccine
- Where
- 2 sites in United States
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific…
- Trial name
- NCT00488683
- Testing
- MenACWY-CRM, DTaP-Hib-IPV, PCV
- Where
- United Kingdom
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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