Bivalent Norovirus Vaccine Study

Status Completed

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 MPL and Al(OH)3 compared to controls. Participants will receive two doses, by 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 Al(OH)3.

- 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

Related Conditions & MeSH terms

Gastroenteritis

Clinical Trial Details

NCT number	NCT01168401
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 1
Start date	September 3, 2010
Completion date	January 9, 2013

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