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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: Completed Phase 1 study of Gastroenteritis, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mi
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 |
What the finished NCT01168401 record still lists
NCT01168401 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,019-participant average among 3 other Gastroenteritis trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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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