Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Takeda ( Inviragen Inc. ) Identifier:
First received: November 16, 2011
Last updated: May 6, 2015
Last verified: May 2015
The purpose of this study is to evaluate the safety and tolerability of a dengue vaccine administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.

Condition Intervention Phase
Biological: DENVax
Biological: Phosphate buffered saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Local Injection site reactions to a dengue vaccine administered subcutaneously [ Time Frame: 30 days post dose ] [ Designated as safety issue: Yes ]
    Local injection site reactions that measure erythema (rash), edema, pain and itching will be evaluated. Active vaccine will be compared to placebo.

  • Systemic reactions to a dengue vaccine administered subcutaneously [ Time Frame: up to Day 120 ] [ Designated as safety issue: Yes ]
    Systemic reactions, including fever and rash, will be evaluated in subjects receiving dengue vaccine and compared to subjects receiving placebo.

Secondary Outcome Measures:
  • Neutralizing Antibody titers of a dengue vaccine against four serotypes of dengue virus [ Time Frame: 30 days post dose 2 ] [ Designated as safety issue: No ]
    Neutralizing antibody titers (at Day 120) will be compared to baseline (day 0) titers.

Estimated Enrollment: 344
Study Start Date: November 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Phosphate buffered saline Biological: Phosphate buffered saline
placebo control
Experimental: DENVax
Live attenuated experimental Dengue vaccine
Biological: DENVax
live attenuated Dengue vaccine, 0.5 ml dose subcutaneously administered at Day 0 and Day 90


Ages Eligible for Study:   18 Months to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • In good health
  • Normal laboratory values at screening

Exclusion Criteria:

  • Abnormal ECG
  • History of significant dermatologic (skin) disease within last 6 months
  • Diabetes mellitus
  • History of any immunodeficiency
  • History of recurring headaches or migraines
  • Hypersensitivity to vaccines
  • Use of amphetamines, opiates, cannabinoids
  • History of alcohol abuse
  • Pregnant or lactating female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01511250

Universidad de Antiquia, PECET
Medillin, Colombia
Puerto Rico
Ponce School of Medicine, CAIMED Center
Ponce, Puerto Rico, 00716
Latin Clinical Trial Center
San Juan, Puerto Rico, 00909
University of Puerto Rico, School of Medicine
San Juan, Puerto Rico, 00936
National University Hospital, Department of Pediatrics
Singapore, Singapore, 119074
Changi General Hospital 2
Singapore, Singapore, 529889
Mahidol University
Bangkok, Thailand, 10400
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Inviragen Inc.
Study Chair: Gilad Gordon, MD Inviragen Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Takeda ( Inviragen Inc. ) Identifier: NCT01511250     History of Changes
Other Study ID Numbers: INV-DEN-203 
Study First Received: November 16, 2011
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Singapore: Health Sciences Authority
Thailand: Ministry of Public Health

Keywords provided by Takeda:
normal healthy adults and children
Safety and tolerability
active vaccine
Dengue virus vaccine
Immune response processed this record on April 27, 2016