New Challenge Pool of Norwalk Virus Inoculum

PHASE1CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

April 30, 2012

Study Completion Date

September 30, 2012

Conditions
Gastroenteritis Norovirus
Interventions
DRUG

Placebo

120 mL of the sodium bicarbonate solution, followed by 82 mL of sterile water, United States Pharmacopeia (USP) without virus; followed by 500 mg of sodium bicarbonate aqueous solution taken 5 minutes after placebo inoculation.

BIOLOGICAL

Norwalk Virus

Prepared and packaged from liquid feces (DC544) by clarification, centrifugation, and serial dilutions; desired doses \[reverse transcription polymerase chain reaction (RT-PCR) Units\] 4800, 48, 4.8, 0.48.

Trial Locations (1)

77030-3411

Baylor College of Medicine - Molecular Virology and Microbiology, Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00138476 - New Challenge Pool of Norwalk Virus Inoculum | Biotech Hunter | Biotech Hunter