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Clinical trialNCT01609257CompletedPhase 1/PHASE2Interventional

Norovirus Bivalent-Vaccine Efficacy Study

SponsorTakedaEnrollment132Prevention From Norovirus Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose. The purpose is also to evaluate the safety of the vaccine and the immunogenicity of the vaccine.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory University

    Atlanta, Georgia, United States

  • Snbl

    Baltimore, Maryland, United States

  • University of Rochester

    Rochester, New York, United States

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, United States

  • Baylor College of Medicine

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Norovirus Bivalent VaccineSaline Comparator
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Jul 2012
Primary completion
1 Mar 2014
Completion
18 Mar 2014
Last update posted
9 Jan 2019
Registered enrollment
132
Registry id
NCT01609257
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.