Clinical trials: Clostridium Infections
Diphtheria, Tetanus
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00654901
- Testing
- DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
- Where
- 4 sites in Mexico
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Acellular Pertussis, Poliomyelitis
Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and…
- Conditions
- Acellular Pertussis, Poliomyelitis, Tetanus, Diphtheria
- Trial name
- NCT01245049
- Testing
- Boostrix PolioTM, RepevaxTM, PriorixTM
- Where
- 13 sites in United Kingdom
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Tetanus, Diphtheria
Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old
The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan.
- Conditions
- Tetanus, Diphtheria, Pertussis
- Trial name
- NCT02089347
- Testing
- Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, Diphtheria and Tetanus toxoids adsorbed
- Where
- 19 sites in Japan
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Clostridium Difficile Infection
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization…
- Trial name
- NCT01259726
- Testing
- VP20621
- Where
- 59 sites in United States, Belgium and 4 more
- Volunteers
- 173 people
- Sponsor
- Shire
Recurrent Clostridium Difficile Infection, Primary Clostridium Difficile Infection
Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI).
- Trial name
- NCT05201079
- Testing
- MBK-01, Fidaxomicin
- Where
- 21 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Mikrobiomik Healthcare Company S.L.
Poliomyelitis, Acellular Pertussis
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.
- Conditions
- Poliomyelitis, Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00611559
- Testing
- Infanrix™ penta, Infanrix™ hexa
- Where
- 3 sites in Russia
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Infections
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged >…
- Trial name
- NCT00214461
- Testing
- C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg)
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
- Trial name
- NCT00772954
- Testing
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy.
- Trial name
- NCT02255305
- Testing
- FMT, Antimicrobials
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Endeavor Health
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
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
Enterocolitis Clostridium Difficile Recurrent
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C.
- Trial name
- PUNCHCD2 (NCT02299570)
- Testing
- RBX2660 (microbiota suspension)
- Where
- 21 sites in United States, Canada
- Volunteers
- 150 people
- Sponsor
- Rebiotix Inc.
Infections, Meningococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy…
- Trial name
- NCT01767376
- Testing
- Meningococcal vaccine GSK134612, Boostrix®
- Where
- 15 sites in Dominican Republic, Germany and 1 more
- Volunteers
- 692 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Infections
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years…
- Trial name
- NCT00127803
- Testing
- Clostridium difficile vaccine
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi
Botulism
Tolerability and Immunogenicity of a Single 40-ug Dose of rBV A/B for the Production of BabyBIG®
This Phase 2, open-label, uncontrolled study designed to evaluate safety, tolerability, and immunogenicity of a single dose of rBV A/B in healthy participants previously immunized with pentavalent botulinum toxoid (or pentavalent…
- Trial name
- NCT06112834
- Testing
- rBV A/B
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- California Department of Public Health
Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to…
- Trial name
- NCT00958308
- Testing
- BIO-K+ CL-1285®
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Bio-K Plus International Inc.
Diphtheria, Tetanus
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02858440
- Testing
- Infanrix-IPV/Hib
- Where
- 5 sites in Russia
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Diphtheria
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Hepatitis B
- Trial name
- NCT01171989
- Testing
- GSK2202083A vaccine, Infanrix hexa™, Menjugate™
- Where
- 9 sites in Poland
- Volunteers
- 391 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Diphtheria
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this…
- Conditions
- Tetanus, Diphtheria, Pertussis
- Trial name
- NCT00467519
- Testing
- Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis), DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
- Where
- 43 sites in United States, Canada
- Volunteers
- 1,045 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company