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Norovirus Bivalent-Vaccine Efficacy Study

NCT01609257 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-01-09

Study results available
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Summary

The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.

Conditions

  • Prevention From Norovirus Infection

Interventions

BIOLOGICAL

Norovirus Bivalent Vaccine

2 doses IM 28 days apart

BIOLOGICAL

Saline Comparator

2 doses IM 28 days apart

Sponsors & Collaborators

Principal Investigators

  • David Bernstein, MD · Cincinatti Children's Hospital

  • Mohamed S Al-Ibrahim, MB, ChB · SNBL Clinical Pharmacology Center

  • David Y Graham, MD · Baylor College of Medicine

  • Robert L Atmar, MD · Children's Hospital Medical Center, Cincinnati

  • G. Marshall Lyon, MD · Emory University

  • John J Treanor, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-16
Primary Completion
2014-03-01
Completion
2014-03-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01609257 on ClinicalTrials.gov