Clinical trials: Gram-Negative Bacterial Infections
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
Lyme Disease
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease
This study will evaluate Advanced Laboratory Services Borrelia diagnostic test by culturing Borrelia spirochetes from human serum in subjects with early or late Lyme disease. This is an 8 month study.
- Trial name
- ALSIBDT (NCT02741609)
- Testing
- Borrelia Diagnostic Test
- Where
- 16 sites in United States
- Volunteers
- 218 people
- Sponsor
- Advanced Laboratory Services, Inc.
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Meningitis, Meningococcal
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 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 months to 35 years.
- Trial name
- NCT05229536
- Testing
- Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
- Where
- China
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Meningococcal Disease
Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old healthy toddlers.
- Trial name
- NCT01994629
- Testing
- MenACWY-CRM, MenACWY-TT
- Where
- 4 sites in Italy
- Volunteers
- 202 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pseudomonas Aeruginosa
Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects
Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.
- Trial name
- EVADE (NCT02696902)
- Testing
- MEDI3902
- Where
- 78 sites in United States, Austria and 12 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Diphtheria, Tetanus
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00617812
- Testing
- Shan5
- Where
- 4 sites in India
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Diphtheria, Polio
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
- Conditions
- Diphtheria, Polio, Pertussis, Hepatitis B
- Trial name
- NCT00619502
- Testing
- DTaP-IPV-HB-PRP~T vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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.
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
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
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
Meningitis, Meningococcal
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
To determine the safety \& immunogenicity of a potential vaccine against meningococcal B disease
- Trial name
- NCT00297687
- Testing
- MnB rLP2086
- Where
- 3 sites in Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Neisseria Meningitidis, Haemophilus Influenzae Type b
Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine
The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with…
- Trial name
- NCT00327184
- Testing
- Haemophilus influenzae type b- and meningococcal serogroup C (vaccine), Infanrix Penta, Infanrix hexa
- Where
- 16 sites in Finland, Italy
- Volunteers
- 709 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Salmonella Infections, Typhoid Fever
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan.
- Conditions
- Salmonella Infections, Typhoid Fever, Bacterial Infections
- Trial name
- NCT01608815
- Testing
- Typhoid Vi polysaccharide
- Where
- 3 sites in Japan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Tetanus
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in…
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT00753649
- Testing
- Infanrix™ hexa
- Where
- 3 sites in Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Hepatitis B
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00317135
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Philippines
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis, Meningococcal Infections
Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis
The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine.
- Trial name
- NCT01482052
- Testing
- meningococcal meningitis conjugate vaccine, quadrivalent
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- JN-International Medical Corporation
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline