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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01511250
First received: November 16, 2011
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.

Condition Intervention Phase
Healthy Biological: TDV Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]
    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 ]
    Systemic reactions, including fever and rash, will be evaluated in participants receiving dengue vaccine and compared to participants 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 ]
    Neutralizing antibody titers (at Day 120) will be compared to baseline (day 0) titers.


Enrollment: 360
Actual Study Start Date: November 16, 2011
Study Completion Date: April 15, 2016
Primary Completion Date: April 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I: TDV 21 to 45 Years (yrs)
TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Placebo Comparator: Part I: Placebo 21 to 45 yrs
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Experimental: Part I: TDV 12 to 20 yrs
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Placebo Comparator: Part I: Placebo 12 to 20 yrs
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 yrs.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Experimental: Part I: TDV 6 to 11 yrs
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Placebo Comparator: Part I: Placebo 6 to 11 yrs
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 yrs.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Experimental: Part I: TDV 1.5 to 5 yrs
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Placebo Comparator: Part I: Placebo 1.5 to 5 yrs
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 yrs.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Experimental: Part II: TDV 1.5 to 11 yrs
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.
Placebo Comparator: Part II: Placebo 1.5 to 11 yrs
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 yrs.
Biological: TDV
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged:21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
Biological: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 yrs, 12 to 20 yrs, 6 to 11 yrs, 1.5 to 5 yrs, and 1.5 to 11 yrs.

  Eligibility

Ages Eligible for Study:   18 Months to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01511250

Locations
Colombia
Program For The Study and Control of Tropical Diseases
Medellin, Colombia
Puerto Rico
Ponce School of Medicine, CAIMED Center
Ponce, Puerto Rico
University of Puerto Rico School of Medicine
San Juan, Puerto Rico
Singapore
Changi General Hospital
Singapore, Singapore
National University Hospital
Singapore, Singapore
Thailand
Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Gilad Gordon, MD Inviragen Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01511250     History of Changes
Other Study ID Numbers: INV-DEN-203
Study First Received: November 16, 2011
Last Updated: June 9, 2017

Keywords provided by Takeda:
normal healthy adults and children
Safety and tolerability
active vaccine
placebo
Dengue virus vaccine
Immune response

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017