Clinical trials: Gram-Negative Bacterial Infections
Healthy Volunteers (Meningococcal Infection)
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135)…
- Trial name
- MET41 (NCT03673462)
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
- Where
- 69 sites in United States, Puerto Rico
- Volunteers
- 2,797 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
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
Healthy
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
- Trial name
- NCT00778388
- Testing
- IC43
- Where
- 3 sites in Austria, Germany
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Tetanus, Diphtheria
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US).
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Trial name
- NCT02587520
- Testing
- Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
- Where
- 20 sites in United States
- Volunteers
- 1,363 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Diagnosis, Gonorrhea
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections
This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples. The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation…
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Trial name
- STING (NCT06352554)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SpeeDx Pty Ltd
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gestational Mother, Streptococcus Agalactiae Infection
Colonization with Group B Streptococcus During Pregnancy
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational.
- Trial name
- PROBIGEST (NCT03671486)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Streptococcus Pneumoniae, Haemophilus Influenzae
Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults.
- Trial name
- NCT00814489
- Testing
- GSK2231395A, Engerix-B
- Where
- Sweden
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Typhoid Fever
Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
- Trial name
- NCT03956524
- Testing
- EuTCV, Typbar-TCV™, Typhim Vi®
- Where
- Philippines
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Meningitis, Meningococcal Infection
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.
- Trial name
- NCT01890759
- Testing
- Meningococcal Diphtheria Toxoid Vaccine
- Where
- 8 sites in India, Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Shigella Infection
Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
- Trial name
- NCT00210288
- Testing
- SC599
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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.
Serious Bacterial Infection
Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Phase 3 study to determine the efficacy, safety, and tolerability of aztreonam- avibactam (ATM- AVI) versus best available therapy (BAT) in the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI)…
- Trial name
- NCT03580044
- Testing
- ATM-AVI, BAT
- Where
- 42 sites in United States, Argentina and 10 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Prevention of the Meningococcal Disease
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01911221
- Testing
- rMenB+OMV NZ
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infections, Gonorrhea
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydial Infections, Genital Herpes
- Trial name
- NCT00262106
- Testing
- PRO 2000/5
- Where
- 6 sites in South Africa, Tanzania and 2 more
- Volunteers
- 9,404 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Meningitis, Meningococcal Meningitis
Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier
The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02633787
- Testing
- Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 4 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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