Clinical trials: Gram-Negative Bacterial Infections
Diphtheria, Tetanus
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00617812
- Testing
- Shan5
- Where
- 4 sites in India
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shantha Biotechnics Limited
Pseudomonas Aeruginosa Pneumonia
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
- Trial name
- NCT03027609
- Testing
- AR-105
- Where
- 111 sites in United States, Australia and 15 more
- Volunteers
- 158 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
Diphtheria, Tetanus
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections
- Trial name
- NCT00255021
- Testing
- Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
- Where
- Thailand
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Sanofi
Acellular Pertussis, Haemophilus Influenzae Type b
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria…
- Conditions
- Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis
- Trial name
- NCT01577732
- Testing
- Infanrix-IPV+Hib™
- Where
- Vietnam
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last…
- Trial name
- NCT02946385
- Testing
- Meningococcal ABCWY Vaccine, Meningococcal B Recombinant vaccine
- Where
- 17 sites in Finland, Poland
- Volunteers
- 604 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Infection
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.
- Trial name
- NCT00643916
- Testing
- Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®), A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
- Where
- 14 sites in United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Lyme Disease
ImmuneSense Lyme Study
ImmuneSense Lyme is a study, which is designed to better understand the immune response to Lyme disease. This is critically important because the immune system may be able to tell us important information about how our own bodies…
- Trial name
- NCT04422314
- Testing
- T-Detect Lyme
- Where
- 34 sites in United States
- Volunteers
- 893 people
- Sponsor
- Adaptive Biotechnologies
Healthy
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time
The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants
- Trial name
- NCT00581035
- Testing
- Prevenar and Meningitec, Prevenar, Meningitec
- Volunteers
- 712 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Diphtheria, Tetanus
Database Surveillance Safety Study of PENTACEL® Vaccine
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae
- Trial name
- NCT00804284
- Testing
- DTaP-IPV/Hib, Other DTap Vaccines
- Where
- United States
- Volunteers
- 62,538 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease, Meningococcal Meningitis
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two…
- Trial name
- NCT00944034
- Testing
- rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ, two doses of rMenB+OMV NZ
- Where
- 72 sites in Belgium, Czechia and 4 more
- Volunteers
- 1,588 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
- Trial name
- NCT00499720
- Testing
- Aztreonam Lysine for Inhalation
- Where
- 65 sites in United States, Puerto Rico
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Lyme Borreliosis, Nervous System
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without…
- Trial name
- NCT03010228
- Testing
- VLA15 with Alum, VLA15 without Alum
- Where
- 5 sites in United States, Belgium
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infections, Meningococcal
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused…
- Trial name
- NCT05082285
- Testing
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine
- Where
- 33 sites in Dominican Republic, Finland and 6 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cholera
A Phase III Randomized, Modified Double-blind, Multi-centric, Comparative Study, to Evaluate the Non-inferiority of Immunogenicity and Safety of Hillchol® (BBV131)to Shanchol™ Along With Lot-to-lot Consistency of Hillchol®(BBV131).
A Phase III randomized, modified double-blind, multi-centric, comparative study, to evaluate the noninferiority of immunogenicity and safety of single strain oral cholera vaccine Hillchol® (BBV131) to the comparator vaccine…
- Trial name
- Hillchol (NCT05507229)
- Testing
- Hillchol vaccine, Shanchol Vaccine
- Where
- 11 sites in India
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Tetanus, Diphtheria
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
Primary objective: To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT02274285
- Testing
- DTaP-IPV/Hib Combined vaccine, DTaP-IPV vaccine and Hib vaccine
- Where
- 12 sites in Japan
- Volunteers
- 424 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Diphtheria, Tetanus
A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)
Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal…
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT06056050
- Testing
- Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (Tdcp), 23-Valent Pneumococcal Polysaccharide Vaccine(PPV23), Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV
- Trial name
- MAGICS IBCS (NCT07170748)
- Where
- 2 sites in Côte d’Ivoire, Kenya
- Volunteers
- 2,950 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics