NCT01168401 - Bivalent Norovirus Vaccine Study | Biotech Hunter

Enrollment

102

Participants

Timeline

Start Date

September 3, 2010

Primary Completion Date

January 1, 2013

Study Completion Date

January 9, 2013

Conditions

Gastroenteritis

Interventions

BIOLOGICAL

NoV GI.1/GII.4 Bivalent VLP Vaccine

"2 Doses 28 days apart Cohort A: 18-49 Years~Cohort A1: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (5/5 mcg)~Cohort A2: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (15/15 mcg)~Cohort A3: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)~Cohort A4: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (150/150 mcg)~Cohort B: 50-64 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)~Cohort C: 65-85 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)~Cohort D: 18-49 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)"

BIOLOGICAL

Saline

Two doses 28 days apart

Trial Locations (3)

14642

University of Rochester Medical Center, Rochester

20910

Navy Medical Research Center, Silver Springs

63104

Saint Louis University, St Louis