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New treatment option for Dengue Fever
Official title A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
ClinicalTrials.gov ID: NCT06665035
What this study is testing
What is TDV?
TDV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for dengue fever.
Also referred to as QDENGA, TAK-003.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 20. Healthy volunteers may be eligible.
You may be able to join if
- Participant eligibility is determined according to the following criteria:
- 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 at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and...
- Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy...
You likely can't join if
- Any participant who meets any of the following criteria will not qualify for randomization:
- Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure...
- Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
- Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the...
- Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré...
- 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...
See the full eligibility criteria
- Participant eligibility is determined according to the following criteria:
- 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 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.
- 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...
- 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.
- Any participant who meets any of the following criteria will not qualify for randomization:
- 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...
- Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
- 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.
- Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
- 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.
- Participant has a known or suspected impairment/alteration of immune function, including:
- 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...
- Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within the 3 months prior to Day 1 (M0).
- Receipt of immunostimulants within 60 days prior to Day 1 (M0).
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
- HIV infection or HIV-related disease.
- Hepatitis B virus infection.
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- Participant has known or suspected abnormalities of splenic or thymic function.
- Participant has a known bleeding diathesis, or any condition/medication that may be associated with a prolonged bleeding time.
- 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.
- Participant has previously received a vaccination against dengue virus (investigational or licensed).
- 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...
- 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...
- Participant has received any of the following:
- 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.
- A coronavirus vaccine within 14 days prior to IMP administration on Day 1 (M0).
- A vaccine authorized for emergency use within 28 days prior to IMP administration on Day 1 (M0).
- Participant is scheduled to receive any other vaccine within 28 days after IMP administration on Day 1 (M0).
- 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.
- 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).
- A first degree relative is involved in the conduct of this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Barranquilla, Atlántico, Colombia
- Cali, Valle del Cauca Department, Colombia
- Pathum Wan, Bangkok, Thailand
- Khlong Luang, Changwat Pathum Thani, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 20 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barranquilla, Atlántico, Colombia; Cali, Valle del Cauca Department, Colombia; Pathum Wan, Bangkok, Thailand; Khlong Luang, Changwat Pathum Thani, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.