Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial Evaluating Safety and Immune Response of 2 Doses of Subcutaneous Dengue Tetravalent Vaccine (TDV) in Children 6 to <21 Months
Led by Takeda · Updated on 2025-07-15
212
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of the Dengue Tetravalent Vaccine (TDV) in children younger than 2 years old. This Phase 3 randomized, double-blind, placebo-controlled trial focuses on infants and toddlers aged 6 to 20 months to understand how well the vaccine activates their immune systems and its safety profile. The study aims to provide detailed information about vaccination with TDV in this young age group. Participants will be divided into groups based on age: 6 to <12 months and 12 to <21 months. Each group will receive two doses of either the TDV vaccine or a placebo (normal saline) injected subcutaneously on Day 1 and Day 90. The study follows an age-descending design, and both vaccinations and placebo injections are administered within the routine vaccination schedule. During the trial, participants will visit the clinic eight times for vaccinations, blood draws, and health checks. Blood samples are collected before vaccination and at several points afterward to assess immune response. Researchers will monitor local and systemic adverse events, medically attended events, and serious adverse events throughout the study, which lasts up to approximately three years. The main outcomes include safety within days after vaccination and immune response measured by antibody levels.
CONDITIONS
Brief Title
A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is aged >=6 to <21 months at the time of entry into the trial.
- Participant is male or female.
- Participant is in good health as determined by medical history, physical exam, and investigator judgment.
- Participant's legally acceptable representative has signed informed consent and privacy authorization.
- Participant and representative can comply with trial procedures and follow-up requirements.
You will not qualify if you...
- Participant has contraindications, warnings, or precautions for TDV vaccination.
- Participant has known allergy to any vaccine components.
- Participant has behavioral, cognitive, or psychiatric issues interfering with participation.
- Participant has history of severe neurological disorders or seizure disorders.
- Participant has illnesses that may interfere with trial results or pose additional risk.
- Participant has known or suspected immune function impairment (including recent immunosuppressive treatments or infections such as HIV, hepatitis B or C).
- Participant has splenic or thymic function abnormalities.
- Participant has bleeding disorders or medications causing prolonged bleeding.
- Participant has serious chronic or progressive diseases deemed unstable.
- Participant has previously received any dengue vaccination.
- Participant has active infection or fever >38.0°C within 3 days before vaccination.
- Participant used antipyretics or analgesics within 24 hours before vaccination.
- Participant received other vaccines within 14 days (inactivated) or 28 days (live) before vaccination.
- Participant is scheduled to receive other vaccines within 28 days after vaccination.
- Participant is enrolled in other clinical trials with investigational products within 30 days before or during this trial.
- Participant has participated in dengue or flavivirus vaccine trials unless known to have received placebo.
- First-degree relative is involved in the conduct of this trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive two subcutaneous injections of either the Tetravalent Dengue Vaccine (TDV) or placebo, given on Day 1 and Day 90.
2 vaccination visits (in-person) on Day 1 and Day 90
Duration - Up to approximately 39 months
Participants are monitored for safety and immune response up to approximately 3 years after the first vaccination.
Multiple follow-up visits on Days 30, 120, 270, 450, 810, and 1170
Trial Site Locations
Total: 4 locations
1
Clinica de la Costa Ltda
Barranquilla, Atlántico, Colombia, 80020
Not Yet Recruiting
2
Centro de Estudios en Infectologia Pediatrica S.A.S
Cali, Valle del Cauca Department, Colombia, 760042
Not Yet Recruiting
3
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330
Not Yet Recruiting
4
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand, 12120
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here