Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Takeda
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
Research Team
MD
Medical Director Clinical Science
Principal Investigator
Takeda
Eligibility Criteria
Inclusion Criteria
Is aged 18 to 60 years inclusive, at the time of randomization.
Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the Investigator.
Treatment Details
Interventions
- Tetravalent Dengue Vaccine (TDV) (Virus Vaccine)
- Yellow Fever Vaccine (YF-17D) (Virus Vaccine)
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Group 3: TDV + YF-17D/TDV/PlaceboExperimental Treatment3 Interventions
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
Group II: Group 2: TDV + Placebo/TDV/YF-17DExperimental Treatment3 Interventions
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
Group III: Group 1: YF-17D + Placebo/TDV/TDVExperimental Treatment3 Interventions
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
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Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier