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NCT00919178 · ClinicalTrials.gov registry record · Phase 1

Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus

A Phase 1 study of Dengue Hemorrhagic Fever and Dengue Shock Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
70
Enrollment target
2
Study locations

NCT00919178: Completed Phase 1 study of Dengue Hemorrhagic Fever and Dengue Shock Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00919178 is a Phase 1 study of Dengue Hemorrhagic Fever and Dengue Shock Syndrome that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00919178, a Phase 1 study of Dengue Hemorrhagic Fever and Dengue Shock Syndrome, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
70 participants
Enrollment target
2
Study locations

Study Summary

Infection with dengue viruses is one of the leading causes of hospitalization and death in children in several tropical Asian counties. The World Health Organization (WHO) estimates that these viruses are responsible for more than 50 million cases of dengue fever (DF) and approximately 0.5 million cases of the more severe disease, dengue hemorrhagic fever/ shock syndrome (DHF/DSS) annually. Because dengue viruses are endemic in most tropical and subtropical regions, keeping more than 2 billion persons at risk for acquiring dengue, the WHO has made development of a dengue vaccine a top priority. The purpose of this study is to evaluate the safety and effectiveness of a candidate DEN4 vaccine aimed at preventing infection with dengue virus serotype 4.

Interventions

  • BIOLOGICAL DEN4 Vaccine Candidate
  • BIOLOGICAL DEN4 Vaccine Placebo

Study Locations (2)

Maryland

  • Center for Immunization Research, Johns Hopkins School of Public Health - Baltimore

Vermont

  • University of Vermont Vaccine Testing Center - Burlington

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2009-07
Est. Completion 2010-05
Phase Phase 1

What the finished NCT00919178 record still lists

NCT00919178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).

The record links to 2 conditions, with Dengue Hemorrhagic Fever appearing as the primary indexed condition, and to 2 interventions - of which DEN4 Vaccine Candidate is the first listed.

NCT00919178 reports a single indexed study location in Maryland, Vermont.

Frequently Asked Questions

What is clinical trial NCT00919178 about?

NCT00919178 is a clinical study titled "Safety of and Immune Response to DEN4 Vaccine Component Candidate for Dengue Virus". Infection with dengue viruses is one of the leading causes of hospitalization and death in children in several tropical Asian counties. The World Health Organization (WHO) estimates that these viruses are responsible for more than 50 million cases of dengue fever (DF) and approximately 0.5 million c...

What is the current status of trial NCT00919178?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2009-07. Estimated completion is 2010-05.

What conditions does trial NCT00919178 study?

This clinical trial studies the following conditions: Dengue Hemorrhagic Fever, Dengue Shock Syndrome.

What interventions are being tested in trial NCT00919178?

The interventions under investigation include: DEN4 Vaccine Candidate (BIOLOGICAL), DEN4 Vaccine Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT00919178?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00919178 being conducted?

This trial has 2 study locations across Maryland, Vermont. 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 NCT00919178's enrollment target sits among peer trials

70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00919178, the US trial registry maintained by the National Library of Medicine. NCT00919178 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.