Clinical trials: Gram-Negative Bacterial Infections
Meningitis, Meningococcal Disease
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
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
- NCT00254995
- Testing
- None administered in this study
- Where
- United States
- Volunteers
- 62,626 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Whooping Cough, Diphtheria
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will…
- Conditions
- Whooping Cough, Diphtheria, Tetanus
- Trial name
- DTaP (NCT05091619)
- Testing
- Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed, Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine
- Where
- 4 sites in China
- Volunteers
- 2,898 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Meningitis, Meningococcal
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.
- Trial name
- NCT00314041
- Testing
- Meningococcal C, DTP/Hib
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Haemophilus Influenzae Type b, Acellular Pertussis
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
- Conditions
- Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria, Tetanus
- Trial name
- NCT00964028
- Testing
- Infanrix™-IPV/Hib
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type B Infection
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
This trial is a randomized, partially blinded, positively controlled phase I clinical study. A total of 160 persons aged 18-59 years, 1-5 years, 6-11 months and 2 months (60-89 days) will be recruited into the trial, and the…
- Trial name
- NCT06621654
- Testing
- Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine, Haemophilus Influenzae Type b Conjugate Vaccine
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
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
Hepatitis B, Tetanus
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in…
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT00753649
- Testing
- Infanrix™ hexa
- Where
- 3 sites in Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease…
- Trial name
- NCT05087056
- Testing
- MenABCWY vaccine
- Where
- 30 sites in United States, Germany
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Safety of 4CMenB Exposure During Pregnancy
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age.
- Trial name
- NCT02640677
- Testing
- 4CMenB
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis, Burkholderia Infections
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF).
- Trial name
- NCT01059565
- Testing
- AZLI
- Where
- 35 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Gilead Sciences
Dysentery, Bacillary
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S.
- Trial name
- NCT03527173
- Testing
- S.sonnei vaccine, S. sonnei 53G challenge strain
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Syphilis, Syphilis Infection
Retrospective Study of iStatis Syphilis Ab Test (POC)
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use.
- Trial name
- NCT06367621
- Testing
- iStatis Syphilis Antibody Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Meningococcal Meningitis, Tetanus
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.
- Conditions
- Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis
- Trial name
- NCT00355121
- Testing
- Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 26 sites in United States
- Volunteers
- 882 people, healthy volunteers welcome
- Sponsor
- Sanofi
Tetanus, Poliomyelitis
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
- Conditions
- Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria
- Trial name
- NCT01086423
- Testing
- Infanrix-IPV/Hib™, Infanrix Hib™, Poliorix™
- Where
- 2 sites in China
- Volunteers
- 985 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01105559
- Where
- 2 sites in South Africa
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Sanofi
Leptospirosis, Jarisch Herxheimer Reaction
Study of the Incidence of Jarisch-Herxheimer Reaction in Leptospirosis Patients in New Caledonia
The objective of the study is to estimate the incidence of Jarisch-Herxheimer Reactions (JHR) during antibiotic treatment of human leptospirosis cases in New Caledonia.
- Trial name
- LEPJARNC (NCT04882046)
- Testing
- Blood collection, Data collection
- Where
- 5 sites in New Caledonia
- Volunteers
- 900 people
- Sponsor
- Institut Pasteur
Diphtheria, Hepatitis B
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity…
- Conditions
- Diphtheria, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00317161
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years.
- Trial name
- NCT00196950
- Testing
- Meningococcal (vaccine)
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline