Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT01168401
Study type Interventional
Source Takeda
Status Completed
Phase Phase 1
Start date September 2010
Completion date January 2013

See also
  Status Clinical Trial Phase
Recruiting NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Recruiting NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Recruiting NCT03502993 - Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Recruiting NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure 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