Clinical trials: Clostridium Infections
Acellular Pertussis, Diphtheria
Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.
The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of…
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus
- Trial name
- NCT00263679
- Testing
- Prophylaxis: Diphtheria, tetanus and pertussis
- Where
- 13 sites in Germany
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00404651
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-HBV-IPV vaccine
- Where
- 6 sites in Mexico
- Volunteers
- 1,189 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Clostridium Difficile
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.
- Trial name
- ECOSPOR (NCT02437487)
- Testing
- SER-109
- Where
- 30 sites in United States
- Volunteers
- 89 people
- Sponsor
- Seres Therapeutics, Inc.
Infections, Clostridium Difficile
Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)
This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.
- Trial name
- NCT01716533
- Testing
- Blood sampling, Stool sample collection
- Where
- 5 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- GlaxoSmithKline
Antibiotics Associated Colitis, Pulmonary Infection
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients.
- Trial name
- NCT01058356
- Where
- South Korea
- Volunteers
- 214 people
- Sponsor
- Pharmbio Korea Co., Ltd.
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
Diphtheria, Tetanus
Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria…
- Trial name
- NCT00601835
- Testing
- Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
- Where
- 2 sites in United States
- Volunteers
- 3,651 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium…
- Trial name
- PUNCH CD (NCT01925417)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 13 sites in United States
- Volunteers
- 34 people
- Sponsor
- Rebiotix Inc.
Tetanus
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
- Trial name
- NCT05664750
- Testing
- TNM002, Human tetanus immunoglobulin (HTIG)
- Where
- 28 sites in China
- Volunteers
- 675 people
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
Diphtheria, Tetanus
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections
- Trial name
- NCT00255021
- Testing
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
- Where
- Thailand
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or…
- Trial name
- MODIFY I (NCT01241552)
- Testing
- MK-3415, MK-6072, MK-3415A
- Volunteers
- 1,452 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Enterocolitis, Pseudomembranous Colitis
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C.
- Trial name
- NCT00106509
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 140 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Genzyme, a Sanofi Company
Tetanus, Haemophilus Influenzae Type b
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.
- Conditions
- Tetanus, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria
- Trial name
- NCT00379977
- Testing
- diphtheria, tetanus, pertussis & Hib vaccine
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus
A Phase Ⅲ Clinical Study of SNA02-48 Injection
The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.
- Trial name
- NCT07633119
- Testing
- SNA02-48, Human tetanus immunoglobulin (HTIG)
- Where
- 30 sites in China
- Volunteers
- 600 people
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Diphtheria, Tetanus
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00291967
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- Philippines
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pseudomembranous Colitis, Clostridium Difficile Diarrhea
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD).
- Conditions
- Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
- Trial name
- NCT00382304
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 8 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Genzyme, a Sanofi Company
Haemophilus Influenzae Type b, Acellular Pertussis
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
- Conditions
- Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Tetanus
- Trial name
- NCT00964028
- Testing
- Infanrix™-IPV/Hib
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day…
- Trial name
- EXTEND (NCT02254967)
- Testing
- Fidaxomicin, Vancomycin
- Where
- 109 sites in Austria, Belgium and 20 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Europe Ltd.
Meningitis, Meningococcal Infection
Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population <2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of…
- Conditions
- Meningitis, Meningococcal Infection, Diphtheria, Tetanus
- Trial name
- NCT01659996
- Testing
- Meningococcal polysaccharide diphtheria toxoid conjugate, Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
- Where
- 58 sites in United States, Puerto Rico
- Volunteers
- 1,394 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Acellular Pertussis
Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January…
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Aspergillosis, Allergic Bronchopulmonary
- Trial name
- NCT02569879
- Testing
- Pertussis maternal immunization
- Where
- Colombia
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline