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A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults

NCT01666652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-25

Study results available
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Summary

The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

4 µg TDENV-PIV with Alum adjuvant

BIOLOGICAL

1 µg TDENV-PIV with AS03B1 adjuvant

OTHER

Phosphate buffered saline

BIOLOGICAL

1 µg TDENV-PIV with Alum adjuvant

BIOLOGICAL

1 µg TDENV-PIV with AS01E1 adjuvant

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Leyi Lin, MD · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-09-30
Completion
2017-11-30

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 NCT01666652 on ClinicalTrials.gov