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Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity

NCT01728792 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-07-18

Study results available
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Summary

This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

TDV

TDV IM or SC injection

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-22
Primary Completion
2013-11-01
Completion
2013-11-21

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 NCT01728792 on ClinicalTrials.gov