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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
WCCT Global
Costa Mesa, California, United States
Frequency of Norovirus Gastroenteritis (NVG)
Occurrence of NVG within 7 days post-challenge
Time frame: 7 days post-challenge
Frequency of Serious Adverse Events (SAEs)
Occurrence of SAEs
Time frame: 42 ± 3 days post-challenge
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