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Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine

NCT02038907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2017-08-08

Study results available
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Summary

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.

Conditions

  • Healthy Volunteers
  • Norovirus, Prevention

Interventions

BIOLOGICAL

Hepatitis A Vaccine

Hepatitis A Vaccine IM injection

BIOLOGICAL

Norovirus Bivalent VLP Vaccine

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2014-03-28
Primary Completion
2015-06-19
Completion
2015-06-19

Countries

  • Belgium

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 NCT02038907 on ClinicalTrials.gov