Clinical trials: Gram-negative Bacterial Infection
Gonorrhea
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of…
- Trial name
- NCT04010539
- Testing
- Gepotidacin, Ceftriaxone, Azithromycin
- Where
- 51 sites in United States, Australia and 4 more
- Volunteers
- 628 people
- Sponsor
- GlaxoSmithKline
Typhoid Fever
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations of Vi-CRM197 conjugate vaccine against S.
- Trial name
- NCT01193907
- Testing
- NVGH Vi-CRM197 12.5 mcg, NVGH Vi-CRM197 5.0 mcg, NVGH Vi-CRM197 1.25 mcg
- Where
- Belgium
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Novartis
Whole Cell Pertussis, Diphtheria
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
- Conditions
- Whole Cell Pertussis, Diphtheria, Hepatitis B, Tetanus
- Trial name
- NCT00169442
- Testing
- Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™, Hiberix™
- Where
- 3 sites in Philippines
- Volunteers
- 745 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis, Whooping Cough
Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.
- Conditions
- Pertussis, Whooping Cough, Tetanus, Lockjaw
- Trial name
- NCT01529645
- Testing
- Acellular pertussis vaccine, Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed), Licensed TdaP booster vaccine
- Where
- Belgium
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Infections, Meningococcal
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal…
- Trial name
- NCT00674583
- Testing
- GSK Biologicals' meningococcal vaccine GSK134612, Menjugate
- Where
- 31 sites in France, Germany
- Volunteers
- 414 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neisseria Meningitidis, Haemophilus Influenzae Type b
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study.
- Trial name
- NCT00359983
- Testing
- MenHibrix (Hib-MenCY-TT), Hib conjugate vaccine (ActHIB)
- Where
- 21 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Meningitis, Meningococcal Meningitis
Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea
The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02864927
- Testing
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- South Korea
- Volunteers
- 1,311 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy Volunteers (Meningococcal Infection)
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by…
- Trial name
- MET33 (NCT03630705)
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 11 sites in Mexico, Russia
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine
The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and…
- Trial name
- NCT01026974
- Testing
- rMenB, rMenB+OMV NZ
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Whole Cell Pertussis, Haemophilus Influenzae Type b
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as…
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus, Diphtheria
- Trial name
- NCT00473668
- Testing
- Zilbrix-Hib, Tritanrix™-HepB/ Hiberix™
- Where
- 3 sites in India
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three…
- Trial name
- NCT01339923
- Testing
- rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine, Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
- Where
- 26 sites in Brazil, Hungary and 2 more
- Volunteers
- 1,409 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Diphtheria, Tetanus
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT04073459
- Testing
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Haemophilus Influenzae Type b, Neisseria Meningitidis
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year…
- Trial name
- NCT00326118
- Testing
- Haemophilus influenzae type b and meningococcal serogroup C (vaccine), Priorix™, Hiberix™
- Where
- 7 sites in Australia
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents…
- Trial name
- NCT00137917
- Testing
- Meningococcal serogroup B vaccine
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Bacterial
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830
A phase I, first-time-in-human (FTIH), randomized, double-blind, placebo controlled, dose-escalation study is conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of GSK3342830 after administration of…
- Trial name
- NCT02751424
- Testing
- GSK3342830
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b
- Trial name
- NCT00871741
- Testing
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Where
- 8 sites in Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects…
- Trial name
- NCT01154088
- Testing
- Mencevax ACWY, GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
- Where
- 3 sites in Panama, Philippines and 1 more
- Volunteers
- 1,170 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Polio
Safety and Immune Response of Different Pediatric Combination Vaccines.
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a…
- Conditions
- Diphtheria, Polio, Pertussis
- Trial name
- NCT00255047
- Testing
- DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined, DTaP-IPV and ActHIB®
- Where
- 36 sites in United States
- Volunteers
- 2,167 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company