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TDENV PIV and LAV Dengue Prime-boost Strategy Using AS03B Adjuvant

NCT03110952 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-04-12

No results posted yet for this study

Summary

The potential synergistic effect of administering 2 dengue vaccine candidates that were previously shown to be safe and immunogenic in humans will be evaluated in this study. A prime-boost study of tetravalent dengue virus purified inactivated vaccine (TDENV-PIV) with the GSK AS03B adjuvant and tetravalent dengue live attenuated virus (TDENV-LAV) vaccine Formulation 17 (F17) will gather data to help better understand the human immune response to dengue vaccination and infection.

This study is being done to evaluate the safety and immune reaction of administering one dose of dengue purified inactivated vaccine and one dose of dengue live attenuated vaccine compared to two doses of inactivated vaccine.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TDENV-PIV

Single-dose vial with pre-filled syringe, subcutaneous injection

BIOLOGICAL

TDENV-F17

Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly

OTHER

Placebo

0.5 mL vial

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • GlaxoSmithKline

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Mark Polhemus · Upstate Medical University, SUNY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-04-30
Completion
2018-04-30

Countries

  • United States

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 NCT03110952 on ClinicalTrials.gov