Clinical trials: Gram-negative Bacterial Infection
Meningitis, Meningococcal Infection
Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population <2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of…
- Conditions
- Meningitis, Meningococcal Infection, Diphtheria, Tetanus
- Trial name
- NCT01659996
- Testing
- Meningococcal polysaccharide diphtheria toxoid conjugate, Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
- Where
- 58 sites in United States, Puerto Rico
- Volunteers
- 1,394 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
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
- NCT00196963
- Testing
- Meningococcal (vaccine)
- Where
- Belgium
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02919293
- Testing
- Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free), Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers…
- Trial name
- NCT03537508
- Testing
- MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine
- Where
- 70 sites in United States, Puerto Rico
- Volunteers
- 2,627 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
A Study to Learn About the Safety of PENBRAYA During Pregnancy
This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the…
- Trial name
- NCT07768163
- Testing
- PENBRAYA
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infections, Meningococcal
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
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 children aged 12 14 months and 3 5 years.
- Trial name
- NCT00126984
- Testing
- Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine, Meningitec
- Where
- 42 sites in Austria, Germany
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP)
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia…
- Conditions
- Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
- Trial name
- APEKS-NP (NCT03032380)
- Testing
- Cefiderocol, Meropenem, Linezolid
- Where
- 119 sites in United States, Belgium and 17 more
- Volunteers
- 300 people
- Sponsor
- Shionogi
Pertussis, Tetanus
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
- Conditions
- Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00319553
- Testing
- ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- Where
- 10 sites in United States
- Volunteers
- 647 people, healthy volunteers welcome
- Sponsor
- Sanofi
Infections, Streptococcal
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
- Trial name
- NCT01485406
- Testing
- Pneumococcal vaccine GSK2830930A, Synflorix™
- Where
- 4 sites in Germany
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
Tetanus, Diphtheria
Confirmatory Study of BK1310 in Healthy Infants
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT03891758
- Testing
- DPT-IPV-Hib, Hib vaccine, DPT-IPV
- Where
- Japan
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Infections, Meningococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the…
- Trial name
- NCT01755689
- Testing
- Meningococcal vaccine GSK134612, Cervarix®, Boostrix®
- Where
- 3 sites in Dominican Republic, Estonia and 1 more
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT)…
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Trial name
- NCT06369220
- Testing
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Where
- 4 sites in United States
- Volunteers
- 331 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF1 (NCT00112359)
- Testing
- AZLI 75 mg three times a day (TID)
- Where
- 53 sites in United States, Australia and 2 more
- Volunteers
- 166 people
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00258895
- Testing
- DAPTACEL®: DTaP
- Where
- 22 sites in United States
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
Infections, Meningococcal
Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to…
- Trial name
- NCT02106390
- Testing
- Meningococcal group B Vaccine, rMenB+OMV NZ, Meningococcal ACWY Conjugate Vaccine, MenACWY
- Where
- 7 sites in Argentina, Mexico
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine…
- Trial name
- NCT01705379
- Testing
- Novartis Meningococcal ACWY Conjugate Vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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