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Norwalk Vaccine Study

NCT00973284 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-08-08

No results posted yet for this study

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.

Conditions

  • Acute Gastroenteritis
  • Norwalk Virus Infection

Interventions

BIOLOGICAL

Norwalk VLP vaccine

Norwalk VLP vaccine dry powder

BIOLOGICAL

mannitol and sucrose

Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder

BIOLOGICAL

Norwalk virus

Norwalk virus solution

Sponsors & Collaborators

Principal Investigators

  • Robert L Atmar, MD · Baylor College of Medicine

  • David I Bernstein, MD · Children's Hospital Medical Center, Cincinnati

  • Clayton D Harro, MD · Johns Hopkins University

  • Mohamed S Al-Ibrahim, MD · SNBL Clinical Pharmacology Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-04
Primary Completion
2010-04-07
Completion
2010-08-18

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 NCT00973284 on ClinicalTrials.gov