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Evaluating the Safety of and Immune Response to a Dengue Vaccine (TV003) in Healthy Adults, Adolescents, and Children in Thailand

NCT02332733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2018-12-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of and immune response to two doses of a dengue vaccine (TV003) given 6 months apart to healthy adults, adolescents, and children in Thailand.

Conditions

  • Dengue

Interventions

BIOLOGICAL

TV003

10\^3 plaque forming units (PFU) of rDEN1 delta 30, 10\^3 PFU of rDEN2/4 delta 30(ME), 10\^3 PFU of rDEN3 delta 30/31-7164, and 10\^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants

BIOLOGICAL

Placebo for TV003

To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Veerachai Watanaveeradej, MD · Phramongkutklao College of Medicine and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-10-26
Completion
2018-10-26

Countries

  • Thailand

Study Locations

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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 NCT02332733 on ClinicalTrials.gov