Clinical trials: Gram-negative Bacterial Infection
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831753
- Testing
- DTaP IPV HB PRP~T vaccine, DTaP-HB-IPV and Haemophilus influenzae type b
- Where
- Peru
- Volunteers
- 263 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4…
- Conditions
- Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis
- Trial name
- NCT00453570
- Testing
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib, Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
- Where
- China
- Volunteers
- 792 people, healthy volunteers welcome
- Sponsor
- Sanofi
Typhoid Fever
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in…
- Trial name
- NCT01438996
- Testing
- NVGH Vi-CRM197
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Novartis
Infections, Meningococcal
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2…
- Trial name
- NCT00135486
- Testing
- MenC-TT, Hib-MenC-TT
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
- Trial name
- NCT00780806
- Testing
- meningococcal B rLP2086 vaccine candidate, Blood draw
- Where
- 3 sites in Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bronchiectasis, Lower Respiratory Infection
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
- Trial name
- NCT02096315
- Testing
- POL7080
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 20 people
- Sponsor
- Polyphor Ltd.
Diphtheria, Acellular Pertussis
Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority.
- Conditions
- Diphtheria, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT03128489
- Testing
- Infanrix-IPV/Hib
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the…
- Trial name
- ELIMINATE (NCT05488340)
- Testing
- LBP-EC01 0.1 x IV dose, LBP-EC01 0.01x IV Dose, LBP-EC01 IV Infusion Dose
- Where
- 17 sites in United States
- Volunteers
- 318 people
- Sponsor
- Locus Biosciences
Meningococcal Infection, Meningitis
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.
- Trial name
- NCT01086969
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
- Where
- 3 sites in India
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic…
- Conditions
- Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
- Trial name
- Tailwind (NCT05616221)
- Testing
- AP-PA02
- Where
- 23 sites in United States
- Volunteers
- 48 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
Infections, Meningococcal
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with…
- Trial name
- NCT03621670
- Testing
- Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 1,196 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Objectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT00802867
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
- Where
- 19 sites in United States
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pseudomonas Aeruginosa Infection
Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation…
- Trial name
- NCT01563263
- Testing
- IC43
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 803 people
- Sponsor
- Valneva Austria GmbH
Gram-negative Bacterial Infection
A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria.
- Trial name
- CHERISH (NCT06462235)
- Testing
- Part A: ATM-AVI Single Dose, Cohorts 1-4, Part B: Multiple-dose ATM-AVI, Cohorts 1-4
- Where
- 32 sites in United States, Argentina and 7 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
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
Diphtheria, Tetanus
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT01491087
- Testing
- DTacP IPV//PRP~T combined vaccine: PENTAXIM®
- Where
- 3 sites in China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company