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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: Completed Phase 2 study of Dengue Hemorrhagic Fever and Dengue Fever, sponsored by Sanofi.

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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).

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

FieldValue
Enrollment Target 260 participants
Start Date 2008-04-17
Est. Completion 2010-02
Phase Phase 2
Sanofi

713 total trials

What the finished NCT00617344 record still lists

NCT00617344 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher).

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 lists 5 locations in 4 states (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.

Similar trials for Dengue Hemorrhagic Fever

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00617344's enrollment target sits among peer trials

260 210th of 2000 higher than 1,789 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00617344, the US trial registry maintained by the National Library of Medicine. NCT00617344 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.