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Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults

NCT02142504 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2017-08-21

Study results available
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Summary

The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs), solicited local and solicited systemic AEs, Adverse Events of Special Interest (AESIs) and AEs leading to participant's withdrawal from the trial.

Conditions

  • Norovirus Prevention

Interventions

BIOLOGICAL

Norovirus Bivalent VLP Vaccine

Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with or without MPL and/or aluminum hydroxide IM injection

DRUG

Placebo (Saline)

Placebo-matching norovirus bivalent VLP vaccine

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

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
2014-05-15
Primary Completion
2016-01-06
Completion
2016-01-06

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 NCT02142504 on ClinicalTrials.gov