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Bivalent Norovirus Vaccine Study
NCT01168401 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01168401 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Maryland, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01168401?
The interventions under investigation include: Saline (BIOLOGICAL), NoV GI.1/GII.4 Bivalent VLP Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01168401?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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