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A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand

NCT00370682 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-05-30

Study results available
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Summary

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.

Conditions

  • Dengue

Interventions

BIOLOGICAL

T-DEN F17

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

BIOLOGICAL

T-DEN F-19

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

OTHER

Placebo Comparator

A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Robert Gibbons, MD, MPH · Department of Virology, Armed Forces Research Institute of Medical Sciences (AFRIMS)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-02-29
FDA Drug
Yes

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370682 on ClinicalTrials.gov