Could a new vaccine shield infants from dengue?
NCT ID NCT06665035
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests a dengue vaccine (TDV) in children aged 6 to 21 months. The goal is to see if the vaccine is safe and triggers a strong immune response. Participants receive two shots three months apart and are monitored for side effects and antibody levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dengue Tetravalent Vaccine (TDV, also known as QDENGA or TAK-003)
- What this could lead to
- If successful, this could provide a safe and effective dengue vaccine for infants, helping prevent a serious mosquito-borne disease in young children.
- What could go wrong
- This is a relatively small phase 3 trial focused on safety and immune response, not yet proving the vaccine prevents dengue in this age group. Side effects like fever or injection site reactions may occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 20 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Centro de Estudios en Infectologia Pediatrica S.A.S
NOT_YET_RECRUITINGCali, Valle del Cauca Department, 760042, Colombia
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Clinica de la Costa Ltda
NOT_YET_RECRUITINGBarranquilla, Atlántico, 80020, Colombia
Contact Email: •••••@•••••
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King Chulalongkorn Memorial Hospital
NOT_YET_RECRUITINGPathum Wan, Bangkok, 10330, Thailand
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Thammasat University Hospital
RECRUITINGKhlong Luang, Changwat Pathum Thani, 12120, Thailand
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