Actively Recruiting
A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
Led by Takeda · Updated on 2025-07-15
212
Participants Needed
4
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.
CONDITIONS
Official 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 less than 21 months at the time of entry into the trial
- Participant can be male or female
- Participant is in good health based on medical history and physical exam
- Legally acceptable representative has signed informed consent and privacy authorization
- Participant and representative can comply with trial procedures and follow-up visits
You will not qualify if you...
- Participant has contraindications or warnings for TDV vaccination as per guidelines
- Participant has known allergy to vaccine components
- Participant has behavioral, cognitive, or psychiatric issues that might interfere with study participation
- Participant has history of severe neurologic disorders or neuro-inflammatory diseases
- Participant has illness or history that could affect trial results or increase risk
- Participant has known or suspected immune system impairments, including recent immunosuppressive treatments or infections like HIV, hepatitis B or C
- Participant has spleen or thymus 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 vaccine
- Participant has active infection or fever above 38.0°C within 3 days before vaccination
- Participant has used antipyretics or pain medications within 24 hours before vaccination
- Participant received other vaccines recently or plans to receive within 28 days after study vaccine
- Participant is enrolled in another clinical trial with investigational products within 30 days before or during this trial
- Participant previously took part in dengue or flavivirus vaccine trials unless they received placebo
- First degree relative is involved in the conduct of this trial
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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