Norwalk Vaccine Study

Status Completed

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.

Clinical Trial Description

The drug being tested in this study is called intranasal Norwalk virus-like particle (VLP) vaccine. Norwalk VLP vaccine is being tested to prevent viral acute gastroenteritis (AGE). This study will look at the illness rate of AGE in people who are administered the Norwalk VLP vaccine.

The study enrolled 98 patients and was conducted in 2 stages: the Vaccination Stage and the Challenge Stage. In the Vaccination Stage participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which remained undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

- Norwalk VLP Vaccine (100 µg VLP) intranasally

- Placebo (dummy inactive powder) - this is a powder that looks like the study drug but has no active ingredient During the Challenge Stage participants were administered live Norwalk virus and were monitored for AGE.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 29 weeks Participants made multiple visits to the clinic and were contacted by telephone 6 months after last dose of study drug for a follow-up assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00973284
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 4, 2009
Completion date	August 18, 2010

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