A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
Launched by TAKEDA · Oct 29, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new dengue vaccine called the Dengue Tetravalent Vaccine (TDV) for infants and toddlers. Dengue fever is a serious illness caused by a virus, and the goal of this study is to find out how safe the vaccine is and how well it works to help young children's immune systems fight off the virus. Children aged 6 to 21 months will receive two doses of the vaccine or a placebo (an inactive substance) over three months. The study will involve visiting a clinic eight times for vaccinations, blood tests, and health checks to monitor how well the vaccine works.
To participate in the study, children must be in good health and meet specific criteria, such as being between 6 and 21 months old. Parents or guardians will need to provide written consent for their child to join the trial. However, some children may not qualify if they have certain health conditions or have received other vaccines recently. Overall, this study aims to gather important information that could help protect young children from dengue fever in the future.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Participant eligibility is determined according to the following criteria:
- • 1. Participant is aged \>=6 to \<21 months at the time of entry into the trial.
- • 2. Participant is male or female.
- • 3. Participant 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.
- • 4. Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
- • 5. The participant and participant's LAR can comply with trial procedures and can be available for the duration of follow-up, according to the LAR.
- • Exclusion Criteria
- Any participant who meets any of the following criteria will not qualify for randomization:
- • 1. Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure (IB)and/or the approved product label (as applicable) in the participating country.
- • 2. Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
- • 3. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
- • 4. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
- • 5. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.
- 6. Participant has a known or suspected impairment/alteration of immune function, including:
- • 1. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, \>=2 mg/kg \[milligrams per kilograms\] body weight/day prednisone \[or equivalent\] for 14 consecutive days, or, \>=20 milligram per day \[mg/day\] prednisone \[or equivalent\] for \>=14 consecutive days) within 60 days prior to Day 1 month 0 (M0) (note: use of corticosteroids by inhaled, intranasal, intraarticular, bursal, tendon injection, or topical routes is allowed).
- • 2. Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 3 months prior to Day 1 (M0).
- • 3. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
- • 4. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
- • 5. HIV infection or HIV-related disease.
- • 6. Hepatitis B virus infection.
- • 7. Hepatitis C virus infection.
- • 8. Genetic immunodeficiency.
- • 7. Participant has known or suspected abnormalities of splenic or thymic function.
- • 8. Participant has a known bleeding diathesis, or any condition/medication that may be associated with a prolonged bleeding time.
- • 9. Participant has a serious chronic or progressive disease deemed to be preclusive to trial entry, that is., not medically stable according to the judgment of the investigator.
- • 10. Participant has previously received a vaccination against dengue virus (investigational or licensed).
- • 11. Participant has a clinically significant active infection (as assessed by the investigator) or body temperature greater than (\>) 38.0 degrees Celsius (°C) (\>100.4 degrees Fahrenheit \[°F\]) within 3 days of intended IMP administration on Day 1 (M0).
- • 12. Participant has used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis vs treatment) must be documented. Trial entry must be delayed to allow for a full 24 hours to have passed since last use of antipyretics and/or analgesic medications.
- 13. Participant has received any of the following:
- • 1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to IMP administration on Day 1 (M0). This includes co-administration with routine vaccines.
- • 2. A coronavirus vaccine within 14 days prior to IMP administration on Day 1 (M0).
- • 3. A vaccine authorized for emergency use within 28 days prior to IMP administration on Day 1 (M0).
- • 14. Participant is scheduled to receive any other vaccine within 28 days after IMP administration on Day 1 (M0).
- • 15. Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or plans to participate in another clinical trial at any time during the conduct of this trial.
- • 16. Participant has taken part in any clinical trial of a dengue or other flavivirus (example, West Nile virus) candidate vaccine, except if it is known that the participant received placebo in the trial(s).
- • 17. A first degree relative is involved in the conduct of this trial.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pathumwan, Bangkok, Thailand
Khlong Luang, Pathum Thani, Thailand
Pathum Wan, Bangkok, Thailand
Khlong Luang, Pathum Thani, Thailand
Barranquilla, Atlantico, Colombia
Cali, Valle Del Cauca, Colombia
Barranquilla, Atlantico, Colombia
Cali, Valle Del Cauca, Colombia
Patients applied
Trial Officials
Study Director Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported