Evaluation of Infectivity & Illness of Norwalk GI.1 Virus Lot 001-09NV in

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT03897309` - Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines	Phase 1
	Completed	`NCT00302640` - Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children	Phase 2/Phase 3

NCT number	NCT03721549
Study type	Interventional
Source	WCCT Global
Contact
Status	Completed
Phase	Phase 1
Start date	October 3, 2018
Completion date	November 28, 2018

Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms