Clinical trials: Infections, Bacterial
Tetanus
Tetanus Immunization in Subjects With No Immunization History or With Tetanus Antibody Levels Below Protective Levels
The goal of this study is to re-evaluate the tetanus antibody pharmacokinetic profile when Tetanus Immune Globulin (Human)(TIG) and Tetanus vaccine (Tetanus toxoid; TT) are given concurrently with strict control on the anatomical…
- Trial name
- NCT00437671
- Testing
- Tetanus Immune Globulin (Human), Diphtheria-Tetanus Toxoids Adsorbed
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Grifols Therapeutics LLC
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Meningococcal Disease
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of…
- Trial name
- NCT02285777
- Testing
- Meningococcal ABCWY
- Where
- 8 sites in United States
- Volunteers
- 189 people
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama
The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.
- Trial name
- NCT01793857
- Testing
- Data collection
- Where
- 13 sites in Panama
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria
A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers
The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine…
- Trial name
- NCT04535037
- Testing
- DTPa-HBV-IPV/Hib, DTaP5-HBV-IPV-Hib, Pneumococcal 13-valent conjugate vaccine
- Where
- 20 sites in Germany, Italy and 1 more
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00258895
- Testing
- DAPTACEL®: DTaP
- Where
- 22 sites in United States
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- Trial name
- NCT04618939
- Testing
- BR-TD-1001, Td-pur inj
- Where
- 9 sites in South Korea
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Candidiasis, Esophageal, HIV Infections
Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
To determine the appropriate duration of amphotericin B therapy for Candida esophagitis. To compare the effectiveness of two different amphotericin B doses in the treatment of biopsy-proven Candida esophagitis.
- Trial name
- NCT00002041
- Testing
- Amphotericin B
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
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
Bacteremia
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
- Trial name
- DIREBT (NCT01919762)
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- T2 Biosystems
Tetanus, Acellular Pertussis
Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV…
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT00148941
- Testing
- SB213503 lot 1, SB213503 lot 2, SB213503 lot 3
- Where
- 24 sites in United States
- Volunteers
- 4,209 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile Infection
Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI).
- Trial name
- NCT01222702
- Testing
- Cadazolid, Vancomycin
- Where
- 23 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Actelion
Urinary Tract Infection Complicated, Acute Pyelonephritis
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis…
- Trial name
- PLEA (NCT03477422)
- Testing
- CSE-1034 (Ceftriaxone + Sulbactam + EDTA), Meropenem
- Where
- 17 sites in India
- Volunteers
- 230 people
- Sponsor
- Venus Remedies Limited
Candidiasis, Vulvovaginal
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection).
- Trial name
- NCT01891331
- Testing
- VT-1161, Fluconazole
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Viamet
Tetanus, Acellular Pertussis
Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
- Trial name
- NCT00835237
- Testing
- Boostrix®, Decavac™
- Where
- 24 sites in United States
- Volunteers
- 1,332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Community-acquired Bacterial Pneumonia
Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
- Trial name
- SOLITAIRE-ORAL (NCT01756339)
- Testing
- Solithromycin, Moxifloxacin
- Where
- 119 sites in United States, Argentina and 15 more
- Volunteers
- 860 people
- Sponsor
- Melinta Therapeutics, Inc.
Tetanus, Acellular Pertussis
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults
The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another…
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01738477
- Testing
- Boostrix
- Where
- 20 sites in United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lyme Disease
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe.
- Trial name
- VALOR (NCT05477524)
- Testing
- VLA15, Saline
- Where
- 129 sites in United States, Canada and 5 more
- Volunteers
- 12,546 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tetanus, Diphtheria
Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.
- Conditions
- Tetanus, Diphtheria, Whooping Cough
- Trial name
- NCT02813486
- Testing
- Biological: GC3111 vaccine, Biological: Boostrix® vaccine
- Where
- 5 sites in South Korea
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Candida Vulvovaginitis
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and…
- Trial name
- DOVE (NCT03253094)
- Testing
- Fluconazole, SCY-078
- Where
- 25 sites in United States
- Volunteers
- 186 people
- Sponsor
- Scynexis, Inc.
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