Clinical trials: Gram-Negative Bacterial Infections
Tuberculosis (TB)
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
- Trial name
- NCT00730795
- Testing
- GSK's candidate Mycobacterium tuberculosis vaccine 692342
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants
This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric…
- Trial name
- NCT01262872
- Testing
- Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), Synflorix™
- Where
- The Gambia
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Glandular and Epithelial, Diphtheria
Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)
Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and…
- Conditions
- Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough
- Trial name
- NCT00325130
- Testing
- Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant)
- Volunteers
- 1,042 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Infections, Meningococcal
Evaluate 4 Different Formulations of Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years.
- Trial name
- NCT00126945
- Testing
- Meningococcal Vaccine
- Where
- Denmark
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lyme Disease
Understanding Tick-borne Diseases
Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic animals in Europe, and currently, the incidence of tick-borne disease is rising.
- Trial name
- OHTICKS (NCT03501407)
- Testing
- Blood samples, skin biopsy
- Where
- France
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Infections, Meningococcal
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the…
- Trial name
- NCT02212457
- Testing
- Bexsero, Havrix, MenABCWY
- Where
- 32 sites in United States, Finland and 1 more
- Volunteers
- 1,063 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Infection
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
- Trial name
- NCT00631995
- Testing
- Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal polysaccharide group C conjugated
- Where
- 5 sites in Australia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV
- Trial name
- MAGICS IBCS (NCT07170748)
- Where
- 2 sites in Côte d’Ivoire, Kenya
- Volunteers
- 2,950 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Immunization; Infection
Phase 3 Study of BK1310 in Healthy Infants
The purpose of this study is to: (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy…
- Trial name
- NCT02992925
- Testing
- DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine）, Hib vaccine
- Where
- 3 sites in Japan
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Dysentery, Bacillary
A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei. A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with…
- Trial name
- NCT03089879
- Testing
- GVGH Shigella sonnei 1790GAHB vaccine
- Where
- France
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02842866
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 907 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single…
- Trial name
- NCT02986854
- Testing
- Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 704 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim in South African Infants
The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age…
- Conditions
- Diphtheria, Tetanus, Haemophilus Infections, Pertussis
- Trial name
- NCT00254969
- Testing
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
- Where
- South Africa
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Diphtheria, Tetanus
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- Aladdin (NCT04618640)
- Testing
- DTaP-IPV combination vaccine
- Where
- 26 sites in South Korea
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Meningococcal Disease
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
- Trial name
- NCT01725217
- Testing
- MenACWY-CRM
- Where
- 4 sites in Russia
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Hepatitis B, Diphtheria
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457495
- Testing
- DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™), HBV (Engerix™-B)
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Serogroup B Meningococcal Meningitis
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
- Trial name
- NCT00657709
- Testing
- Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2), Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
- Where
- 66 sites in Austria, Czechia and 3 more
- Volunteers
- 3,630 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines