Clinical trials: Gram-Negative Bacterial Infections
Bronchiectasis
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas…
- Trial name
- NCT00775138
- Testing
- 280 mg Arikayce™, 560 mg Arikayce™
- Where
- 18 sites in United States, Bulgaria and 7 more
- Volunteers
- 64 people
- Sponsor
- Insmed Incorporated
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Pseudomonas
Phase I Study of Colistin Methanesulfonate Sodium
This is a clinical study protocol for a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability and pharmacokinetics of intravenous dosing of Colistin…
- Trial name
- NCT01449838
- Testing
- Colistimethate sodium, Saline
- Where
- Australia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY…
- Trial name
- NCT00856297
- Testing
- MenACWY-CRM conjugate vaccine, Licensed comparator
- Where
- 32 sites in United States
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Lung Diseases, Pulmonary Disease
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects…
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung
- Trial name
- NCT03309358
- Testing
- Inhaled SNSP113
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Synspira, Inc.
Urinary Tract Infections, Infection
Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections
The purpose of this study is to compare the effects of a cranberry juice beverage on rates of Urinary tract infection (UTI) recurrence in women with a history of UTI.
- Conditions
- Urinary Tract Infections, Infection, Urologic Diseases
- Trial name
- NCT01776021
- Testing
- cranberry juice
- Where
- 17 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Ocean Spray Cranberries, Inc.
Meningococcal Disease, Meningococcal Meningitis
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine given alone or concomitantly with MenACWY-CRM to healthy adults.
- Conditions
- Meningococcal Disease, Meningococcal Meningitis, Hepatitis A, Hepatitis B
- Trial name
- NCT01453348
- Testing
- MenACWY-CRM, Combined inactivated hepatitis A & recombinant hepatitis B, Recombinant hepatitis B vaccine
- Where
- 4 sites in Germany
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Gram-negative Bacterial Infections
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.
- Trial name
- NCT05639647
- Testing
- ATM-AVI, BAT
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Meningococcal Disease, Meningococcal Meningitis
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.
- Trial name
- NCT01210885
- Testing
- Meningococcal Vaccine
- Where
- 8 sites in Chile, Colombia and 1 more
- Volunteers
- 495 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious…
- Trial name
- NCT01437267
- Testing
- Vi-CRM197 vaccine, Pneumococcal conjugate vaccine, Vi Polysaccharide (PS) vaccine
- Where
- Philippines
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Novartis
Diphtheria, Tetanus
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00877357
- Testing
- Shan 5
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Epidemic Meningitis, Meningococcal Vaccines
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.
- Trial name
- NCT07505836
- Testing
- experimental vaccine, Active Comparator vaccine
- Where
- 2 sites in China
- Volunteers
- 1,040 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Acellular Pertussis, Tetanus
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Booster and immune memory study
- Conditions
- Acellular Pertussis, Tetanus, Hepatitis B, Diphtheria
- Trial name
- NCT00307567
- Testing
- Pneumococcal (vaccine)
- Where
- 51 sites in Germany
- Volunteers
- 689 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and…
- Trial name
- NCT01733069
- Testing
- APTIMA COMBO 2 Assay (AC2 Assay)
- Where
- 7 sites in United States
- Volunteers
- 1,912 people, healthy volunteers welcome
- Sponsor
- Gen-Probe, Incorporated
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
Diphtheria, Tetanus
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
- Trial name
- NCT00325156
- Testing
- GSK Biologicals' combined DTPa-IPV/Hib vaccine
- Where
- Singapore
- Volunteers
- 2,590 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline