Clinical trials: Gram-negative Bacterial Infection
Haemophilus Infections, Diphtheria
Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.
- Conditions
- Haemophilus Infections, Diphtheria, Tetanus, Polio
- Trial name
- NCT00855855
- Testing
- DTaP-IPV/Hib
- Where
- 59 sites in United States
- Volunteers
- 20,830 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Uncomplicated Urogenital Gonorrhea
Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea
This study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea.
- Trial name
- SOLITAIRE-U (NCT02210325)
- Testing
- solithromycin, ceftriaxone, azithromycin
- Where
- 5 sites in United States, Australia
- Volunteers
- 264 people
- Sponsor
- Melinta Therapeutics, Inc.
Haemophilus Influenzae Type b, Neisseria Meningitidis
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6…
- Trial name
- NCT00345579
- Testing
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014, ActHIB, Pediarix/Infanrix Penta
- Where
- 63 sites in United States, Mexico
- Volunteers
- 4,432 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lyme Disease
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
- Trial name
- NCT03581279
- Testing
- T2Lyme Panel testing
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- T2 Biosystems
Epidemic Meningitis
Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any…
- Trial name
- NCT06389513
- Testing
- MCV4
- Where
- China
- Volunteers
- 3,011 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Streptococcal, Streptococcus Pneumoniae
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S.
- Trial name
- FinIP (NCT00861380)
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
- Where
- Finland
- Volunteers
- 41,188 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Diphtheria, Pertussis
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from…
- Conditions
- Diphtheria, Pertussis, Tetanus
- Trial name
- NCT01267058
- Testing
- GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine, Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pertussis Vaccines, Pertussis (Whooping Cough)
Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received…
- Trial name
- NCT06888076
- Where
- Thailand
- Volunteers
- 2,700 people, healthy volunteers welcome
- Sponsor
- BioNet-Asia Co., Ltd.
Infections, Meningococcal
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2…
- Trial name
- NCT00427908
- Testing
- GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY, Meningitec™
- Where
- 11 sites in Finland
- Volunteers
- 613 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02199691
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 1,715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Pertussis
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all…
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01357720
- Testing
- Quinvaxem, Quinvaxem/Tritanrix
- Where
- Philippines
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Pertussis
Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who…
- Trial name
- NCT02382913
- Testing
- aP booster, TdaP booster, Licensed TdaP booster (Boostrix®)
- Where
- Belgium
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningitis, Meningococcal Disease
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.
- Trial name
- NCT00728260
- Testing
- None administered in this study
- Where
- United States
- Volunteers
- 1,421 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis, CF
Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
- Conditions
- Cystic Fibrosis, CF, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- NCT01055847
- Testing
- Aztreonam for Inhalation (AI)
- Where
- 20 sites in United States
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Haemophilus Influenzae, Haemophilus Influenzae Type a
Phase 2 Trial of a Haemophilus Influenzae Serotype a (Hia) Glycoconjugate Vaccine
This study is testing a vaccine designed to protect against Haemophilus influenzae type a (Hia), a bacterium that can cause serious infections.This is a phase 2 trial.
- Trial name
- NCT07743008
- Testing
- Haemophilus influenzae serotype a vaccine candidate
- Where
- 2 sites in Canada
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- InventVacc Biologicals Inc.
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Meningitis, Meningococcemia
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine…
- Trial name
- NCT00771849
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Haemophilus Influenzae Type b (Hib) vaccine
- Where
- 2 sites in United Kingdom
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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