Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

Completed · Phase 2

Conditions studied: Healthy Volunteers, Norovirus

In brief

The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.

Key facts

Study ID

NCT03039790

Run by

Takeda

People needed

528

Starts

2017-02-21

Expected to finish

2021-07-22

Last updated by the study team

2022-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female participants who previously received at least 1 dose of NoV vaccine in trials NOR-107 (NCT02038907), NOR-210 (NCT02475278) and NOR-204 (NCT02661490), have baseline and post-vaccination data, and completed the primary vaccination trial protocol as initially described.

You may not qualify if…

• Participation in any clinical trial is allowed, on condition that no investigational product is administered within 30 days prior to blood sampling.
• In the opinion of the investigator, the participant is not medically eligible to provide blood specimens.
• Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.

Where it is running

• Simon-Williamson Clinic/Synexus Clinical Research US, Inc — Birmingham, Alabama, United States
• Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C. — Fountain Hills, Arizona, United States
• Synexus Clinical Research US, Inc/Southwest Family Medicine — Littleton, Colorado, United States
• Miami Research Associates — Miami, Florida, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• St. Louis University, School of Medicine — St Louis, Missouri, United States
• Regional Clinical Research Inc. — Endwell, New York, United States
• University of Rochester — Rochester, New York, United States
• Benchmark Research Austin — Austin, Texas, United States
• Universiteit Antwerpen — Antwerp, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium

Full record on ClinicalTrials.gov

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