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COMPLETED Phase 2

Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US

NCT00617344 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 2, 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 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT00617344 reports 5 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Louisiana. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00617344?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial