Clinical trials: Gram-negative Bacterial Infection
Meningitis, Meningococcal
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.
- Trial name
- NCT06113198
- Testing
- rMenB+OMV NZ
- Where
- 8 sites in South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Proven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis
Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)
The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants.
- Trial name
- NCT02266706
- Testing
- Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, Ceftolozane/Tazobactam 20/10 mg/kg
- Volunteers
- 43 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Meningitis, Meningococcal Infection
Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19…
- Trial name
- NCT00269477
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 8 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pneumonia, Bacterial
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV…
- Trial name
- IASIS (NCT01969799)
- Testing
- Amikacin fosfomycin inhalation solution
- Where
- 41 sites in United States, France and 5 more
- Volunteers
- 143 people
- Sponsor
- Cardeas Pharma
Meningococcal Disease
Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy Adolescents
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
- Trial name
- NCT00297817
- Testing
- serogroup B meningococcal vaccine
- Where
- 8 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants
This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of oral ETX0282 when administered alone and in…
- Trial name
- NCT03491748
- Testing
- ETX0282, Cefpodoxime proxetil
- Where
- Australia
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Bronchiectasis, Lower Respiratory Infection
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
- Trial name
- NCT02096315
- Testing
- POL7080
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 20 people
- Sponsor
- Polyphor Ltd.
Meningococcal Meningitis
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
- Trial name
- NCT00310817
- Testing
- MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine, MenACWY-CRM conjugate vaccine, unadjuvanted
- Where
- 2 sites in Finland, Poland
- Volunteers
- 623 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Lyme Borreliosis
Performance Evaluation of the DualDur In Vitro Diagnostic System in the Diagnosis of Lyme Borreliosis
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.
- Trial name
- NCT03873974
- Testing
- DualDur dark-field microscopic test, DualDur dark-field automatic microscopic test, Western blot IgM and IgG
- Where
- 8 sites in Austria, Czechia and 4 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Lyme Diagnostics Ltd.
Meningitis, Meningococcal Disease
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
- Trial name
- NCT00254995
- Testing
- None administered in this study
- Where
- United States
- Volunteers
- 62,626 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Haemophilus Influenzae Type b, Neisseria Meningitidis
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster.
- Trial name
- NCT00322335
- Testing
- Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta, Infanrix™ hexa
- Where
- 12 sites in Spain
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01031303
- Testing
- DTacP-IPV combined vaccine (TETRAXIM™)
- Where
- 2 sites in Thailand
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Sanofi
Typhoid Fever
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
- Trial name
- NCT00498654
- Testing
- Ty800 (Salmonella typhi) Oral Vaccine
- Where
- 5 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Avant Immunotherapeutics
Meningococcal Disease
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.
- Trial name
- NCT02140762
- Testing
- MenABCWY, MenACWY
- Where
- 8 sites in United States
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
Infections, Meningococcal
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with…
- Trial name
- NCT03621670
- Testing
- Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 1,196 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers (Meningococcal Infection)
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by…
- Trial name
- MET33 (NCT03630705)
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 11 sites in Mexico, Russia
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00092469
- Testing
- V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Leptospirosis
Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine
The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than a total of 8 doses (2 doses two weeks apart…
- Trial name
- SPT-001 (NCT03497572)
- Where
- 2 sites in France
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Imaxio
Diphtheria, Pertussis
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all…
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01917357
- Testing
- Quinvaxem in Uniject, Quinvaxem in single dose vials
- Where
- Philippines
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV