Clinical trials: Gram-Negative Bacterial Infections
Cholera
A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131).
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine…
- Trial name
- Hillchol (NCT05507229)
- Testing
- Hillchol vaccine, Shanchol Vaccine
- Where
- 11 sites in India
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
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
Meningococcal Disease, Meningococcal Meningitis
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01478347
- Testing
- Recombinant meningococcal B + OMV NZ
- Where
- Italy
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered…
- Trial name
- NCT00758264
- Testing
- Meningococcal vaccine GSK134612, Pneumococcal vaccine GSK1024850A
- Where
- 5 sites in Mexico, Taiwan
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Pertussis
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B).
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01362517
- Testing
- Quinvaxem
- Where
- Vietnam
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Rotavirus
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix…
- Trial name
- NCT02907216
- Testing
- Squarekids, Rotarix
- Where
- 11 sites in Japan
- Volunteers
- 292 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neisseria Meningitidis, Haemophilus Influenzae Type b
Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age.
- Trial name
- NCT00891176
- Testing
- MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A, PrevenarTM
- Where
- 28 sites in Germany, Poland and 1 more
- Volunteers
- 582 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa.
- Trial name
- NCT00481689
- Testing
- Cipro XR (Ciprofloxacin, BAYQ3939)
- Where
- 35 sites in United States
- Volunteers
- 500 people
- Sponsor
- Bayer
Poliomyelitis, Diphtheria
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety…
- Conditions
- Poliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00635128
- Testing
- Boostrix-Polio
- Where
- 38 sites in Germany
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic…
- Conditions
- Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
- Trial name
- Tailwind (NCT05616221)
- Testing
- AP-PA02
- Where
- 23 sites in United States
- Volunteers
- 48 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Shigellosis
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
- Trial name
- NCT02388009
- Testing
- Flexyn2a, Flexyn2a plus adjuvant
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Meningitis, Meningococcal
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine…
- Trial name
- NCT03493919
- Testing
- rMenB+OMV NZ vaccine, Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
- Where
- 6 sites in Australia, Germany
- Volunteers
- 1,021 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pseudomonas Aeruginosa, Cystic Fibrosis
Open Label Extension to Bridging Study CTBM100C2303
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas…
- Trial name
- NCT00982930
- Testing
- Tobramycin inhalation powder
- Where
- 2 sites in Estonia, Russia
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Meningococcal
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in…
- Trial name
- NCT00465816
- Testing
- Nimenrix (Meningococcal vaccine 134612), Twinrix
- Where
- 6 sites in Denmark, Sweden
- Volunteers
- 611 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement…
- Trial name
- NCT02141516
- Testing
- rMenB+OMV
- Where
- 20 sites in Italy, Poland and 3 more
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningococcal Disease, Infections, Meningococcal
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in…
- Trial name
- NCT02173704
- Testing
- Bexsero®, Routine vaccines
- Where
- 2 sites in Taiwan
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
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
Pneumonia, Ventilator Associated Pneumonia
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of…
- Trial name
- NCT00851435
- Testing
- KBPA-101
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Kenta Biotech Ltd