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NCT01168401 · ClinicalTrials.gov registry record · Phase 1
Bivalent Norovirus Vaccine Study
A Phase 1 study of Gastroenteritis, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 3
- Study locations
NCT01168401 is a Phase 1 study of Gastroenteritis that has completed, run by Takeda. The registered enrollment target is 102 participants, below the 1,019-participant average among 3 other Gastroenteritis trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT01168401, a Phase 1 study of Gastroenteritis, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 3
- Study locations
Study Summary
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart. The hypotheses for this study are: * The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3. * Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose. * The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Conditions Studied
Interventions
- BIOLOGICAL Saline
- BIOLOGICAL NoV GI.1/GII.4 Bivalent VLP Vaccine
Study Locations (3)
Maryland
- Navy Medical Research Center - Silver Springs
Missouri
- Saint Louis University - St Louis
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2010-09-03 |
| Est. Completion | 2013-01-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01168401
The ClinicalTrials.gov registry entry for NCT01168401 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,019-participant average among 3 other Gastroenteritis trials with a reported enrollment target (90% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastroenteritis appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT01168401 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Maryland, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT01168401 about?
NCT01168401 is a clinical study titled "Bivalent Norovirus Vaccine Study". Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart. The hypotheses for thi...
What is the current status of trial NCT01168401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2010-09-03. Estimated completion is 2013-01-09.
What conditions does trial NCT01168401 study?
This clinical trial studies the following conditions: Gastroenteritis.
What interventions are being tested in trial NCT01168401?
The interventions under investigation include: Saline (BIOLOGICAL), NoV GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01168401?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01168401 being conducted?
This trial has 3 study locations across Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.