Clinical trials: Gram Negative Infections
- Condition Gram Negative Infections
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Poliomyelitis, Diphtheria
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety…
- Conditions
- Poliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00635128
- Testing
- Boostrix-Polio
- Where
- 38 sites in Germany
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population…
- Trial name
- NCT01766206
- Testing
- MenACWY-CRM (Menveo)
- Where
- 54 sites in South Korea
- Volunteers
- 3,948 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Salmonella Infections, Typhoid Fever
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan.
- Conditions
- Salmonella Infections, Typhoid Fever, Bacterial Infections
- Trial name
- NCT01608815
- Testing
- Typhoid Vi polysaccharide
- Where
- 3 sites in Japan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pneumonia, Bacterial
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia
To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV…
- Trial name
- IASIS (NCT01969799)
- Testing
- Amikacin fosfomycin inhalation solution
- Where
- 41 sites in United States, France and 5 more
- Volunteers
- 143 people
- Sponsor
- Cardeas Pharma
Meningococcal Disease, Meningococcal Meningitis
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed…
- Trial name
- NCT01018732
- Testing
- Novartis Meningococcal (MenACWY-CRM) vaccine
- Where
- 3 sites in United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.
- Trial name
- NCT01139021
- Testing
- rMenB+OMV NZ
- Where
- 19 sites in Czechia, Finland
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pertussis, Whooping Cough
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose…
- Trial name
- NCT03942406
- Testing
- BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
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
Meningococcal Infection
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
- Trial name
- NCT01340898
- Testing
- Meningococcal vaccine GSK 134612, SynflorixTM, Infanrix-IPV/HiberixTM
- Where
- 2 sites in Lebanon, Mexico
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram…
- Conditions
- Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
- Trial name
- REVISIT (NCT03329092)
- Testing
- ATM-AVI, MTZ, MER
- Where
- 157 sites in United States, Argentina and 19 more
- Volunteers
- 422 people
- Sponsor
- Pfizer
Meningococcal Disease
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose…
- Trial name
- NCT00847145
- Testing
- 1a - rMenB+OMV NZ and routine vaccines, 1b - rMenB+OMV NZ and routine vaccines, 2a - Routine and rMenB+OMV NZ vaccines
- Where
- 59 sites in Austria, Czechia and 3 more
- Volunteers
- 2,249 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Meningococcal Infections, Meningococcal Meningitis
Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years
Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune®…
- Trial name
- NCT00874549
- Testing
- Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide, Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 6 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Meningococcal, Meningococcal Vaccines
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age.
- Trial name
- NCT01144663
- Testing
- Nimenrix™, Menjugate®, NeisVac-CTM
- Where
- 44 sites in Estonia, Germany and 1 more
- Volunteers
- 2,095 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY…
- Trial name
- NCT00856297
- Testing
- MenACWY-CRM conjugate vaccine, Licensed comparator
- Where
- 32 sites in United States
- Volunteers
- 389 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02199691
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 1,715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Fever, Neutropenia
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
- Conditions
- Fever, Neutropenia, Gram-positive Bacterial Infections, Pseudomonas Infection
- Trial name
- NCT00529282
- Testing
- Ceftobiprole Medocaril, Cefepime with or without vancomycin
- Volunteers
- 2 people
- Sponsor
- Basilea Pharmaceutica