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NCT00617344 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
A Phase 2 study of Dengue Hemorrhagic Fever and Dengue Fever, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
- 5
- Study locations
NCT00617344 is a Phase 2 study of Dengue Hemorrhagic Fever and Dengue Fever that has completed, run by Sanofi. The registered enrollment target is 260 participants. The trial reports 5 study locations across 4 states.
The verdict
NCT00617344, a Phase 2 study of Dengue Hemorrhagic Fever and Dengue Fever, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Conditions Studied
Interventions
- BIOLOGICAL Tetravalent CYD Dengue Vaccine , 5555 formulation
- BIOLOGICAL Tetravalent CYD Dengue Vaccine , 5553 formulation
- BIOLOGICAL Tetravalent CYD Dengue Vaccine, 4444 formulation
Study Locations (5)
California
- Investigational Site 002 - San Diego
- Investigational Site 005 - Vallejo
Alabama
- Investigational Site 004 - Hoover
Louisiana
- Investigational Site 001 - New Orleans
Missouri
- Investigational Site 003 - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2008-04-17 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00617344
The ClinicalTrials.gov registry entry for NCT00617344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Dengue Hemorrhagic Fever appearing as the primary indexed condition, and to 3 interventions - of which Tetravalent CYD Dengue Vaccine , 5555 formulation is the first listed.
NCT00617344 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00617344 about?
NCT00617344 is a clinical study titled "Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US". This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives ...
What is the current status of trial NCT00617344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2008-04-17. Estimated completion is 2010-02.
What conditions does trial NCT00617344 study?
This clinical trial studies the following conditions: Dengue Hemorrhagic Fever, Dengue Fever, Dengue Virus.
What interventions are being tested in trial NCT00617344?
The interventions under investigation include: Tetravalent CYD Dengue Vaccine , 5555 formulation (BIOLOGICAL), Tetravalent CYD Dengue Vaccine , 5553 formulation (BIOLOGICAL), Tetravalent CYD Dengue Vaccine, 4444 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00617344?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00617344 being conducted?
This trial has 5 study locations across Alabama, California, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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