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Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children

NCT02153112 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2019-04-01

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) combined with aluminum hydroxide for further development in children.

Conditions

Interventions

BIOLOGICAL

GI.1/GII.4 (15/15)

Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (15/50)

Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (50/50)

Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

BIOLOGICAL

GI.1/GII.4 (50/150)

Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection

DRUG

Placebo

Placebo saline solution

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-23
Primary Completion
2018-06-20
Completion
2018-06-20

Countries

  • Colombia
  • Finland
  • Panama

Study Locations

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Entities

Drugs
Diseases
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 NCT02153112 on ClinicalTrials.gov