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Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)

NCT01435811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-07

No results posted yet for this study

Summary

The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines and antivirals.

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

Norovirus challenge pool (GII.4, CIN-1)

Norovirus challenge pool (GII.4, CIN-1)

Sponsors & Collaborators

  • LigoCyte Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-04-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435811 on ClinicalTrials.gov