Infection Clinical Trial
Phase 1, Randomized Controlled Dose Escalation, Safety and Immunogenicity Study of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine Adjuvanted With Monophosphoryl Lipid A (MPL) and Aluminum Hydroxide (AlOH) in Adults
|Start date||September 2010|
|Completion date||January 2013|
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four
dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with
monophosphoryl lipid A (MPL) and aluminum hydroxide (AlOH) compared to controls. Subjects
will receive two doses, by intramuscular (IM) injection, 28 days apart.
The hypotheses for this study are:
- The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and AlOH.
- Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose.
- The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|Recruiting||NCT02899143 - Short-course Antimicrobial Therapy in Sepsis||Phase 2|
|Recruiting||NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure||Phase 1|
|Recruiting||NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection||N/A|
|Recruiting||NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery||Phase 3|
|Active, not recruiting||NCT02768454 - Antimicrobials Stewardship by Pharmacist||N/A|
|Recruiting||NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates||N/A|
|Recruiting||NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts||N/A|
|Completed||NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection||Phase 3|
|Recruiting||NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection||N/A|
|Terminated||NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants||Phase 1|
|Completed||NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)||N/A|
|Recruiting||NCT01085669 - Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)||N/A|
|Not yet recruiting||NCT00698919 - Bacterial Infection Diagnosis Using Blood DNA||N/A|
|No longer available||NCT00547235 - Emergency Use of Adoptive Immunotherapy With CMV-Specific T Cells After Donor Bone Marrow Transplant of an Infant With Immunodeficiency Syndrome and CMV Infection||N/A|
|Completed||NCT00596167 - Intradialytic Drug Removal by Short-daily Hemodialysis||N/A|
|Completed||NCT00177736 - Pharmacodynamic Parameters of Two Different Doses of Cefepime||Phase 4|
|Active, not recruiting||NCT00020865 - Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia||Phase 3|
|Completed||NCT00005496 - Inflammation, Infection, and Future Cardiovascular Risk||N/A|
|Completed||NCT00000581 - Granulocyte Transfusion Study||Phase 3|
|Recruiting||NCT02948335 - Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital||N/A|