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Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults

NCT02421367 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-09-25

No results posted yet for this study

Summary

This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.

Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)

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

  • Leyi Lin, M.D. · USAMRMC/WRAIR

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-12-31
Completion
2018-03-31

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 NCT02421367 on ClinicalTrials.gov