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

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Clinical Trial Details
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