Dengue FeverPhase 3NCT06665035
A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
A Phase 3 study testing TDV in people with Dengue Fever, run by Takeda at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- What is being tested?
- TDV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Jun 2025to 3 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 nature of the trial has been explained according to local regulatory requirements.
- 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.
Who cannot join
- 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 participating country.
- 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.
Show all 29Show fewer
- 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 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).
- 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 administration on Day 1 (M0).
- 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.
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Colombia2 sites, 2 recruiting
- Not yet recruiting
Clinica de la Costa Ltda
Barranquilla, Atlántico, 80020
Site Contact, +573 157-6091 ext. 10, jpiedraitaclinicadelacosta@gmail.com
Jorge Antonio Piedrahita Olier
- Not yet recruiting
Centro de Estudios en Infectologia Pediatrica S.A.S
Cali, Valle del Cauca Department, 760042
Site Contact, +572 513-3762, pio.lopez@ceiponline.org
Pio Lopez
Thailand2 sites, 2 recruiting
- Recruiting
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, 12120
Site Contact, +66 2 926-9514, dr.auchara@yahoo.com
Auchara Tangsathapornpong
- Not yet recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
Site Contact, +66 8 948-18922, suvaporn.a@chula.ac.th
Suvaporn Anugulruengkitt
About this study
Official title: A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ≥6 Months to <21 Months of Age
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
- Dengue Fever
- Being tested
- TDV, Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDVBiological
Also called QDENGA, TAK-003
TDV SC injection.
PlaceboOther
Placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months) | Experimental | Participants with the age group >= 12 to < 21 months receive TDV 0.5 mL subcutaneous (SC) injection, on Day 1 and Day 90. Receives: Biological: TDV |
| Cohort 1: Placebo (Age group: >=12 to <21 months) | Experimental | Participants with the age group >= 12 to < 21 months receive placebo (normal saline), SC injection, on Day 1 and Day 90. Receives: Other: Placebo |
| Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months) | Experimental | Participants with the age group >=6 to <12 months receive TDV, 0.5 mL SC injection, on Day 1 and Day 90. Receives: Biological: TDV |
| Cohort 2: Placebo (Age group: >=6 to <12 months) | Experimental | Participants with the age group >=6 to <12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 7 Days post-vaccination at Day 1
Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 7 days post-vaccination at Day 90
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature greater than or equal to [>=] 38-degree Celsius [C], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 14 days post-vaccination at Day 1
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature >= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 14 days post-vaccination at Day 90
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 1
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).
Measured: Within 28 days post-vaccination at Day 1
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 90
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).
Measured: Within 28 days post-vaccination at Day 90
Percentage of Participants with Medically-attended AEs (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.
Measured: From Day 1 through the end of trial (up to Day 1170)
Percentage of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.
Measured: From Day 1 through the end of trial (up to Day 1170)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
Measured: Day 120
Secondary outcomes (3)
GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates for 4 Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer >=10 against each of the four dengue virus serotypes. The four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
Measured: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer >=10 against multiple (2, 3, or 4) dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start16 Jun 2025
- Primary completion3 Mar 2030 (estimated)
- Study completion3 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665035
- Sponsor's protocol ID
- DEN-306
- Other IDs
- 2023-001084-54, 2023
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ≥6 Months to <21 Months of Age
- ClinicalTrials.gov ID
- NCT06665035
- Acronym / sponsor ID
- DEN-306
- Conditions
- Dengue Fever
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 3 Mar 2030 (estimated)
- Study completion
- 3 Mar 2030 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months) | Experimental | Biological: TDVParticipants with the age group >= 12 to < 21 months receive TDV 0.5 mL subcutaneous (SC) injection, on Day 1 and Day 90. |
| Cohort 1: Placebo (Age group: >=12 to <21 months) | Experimental | Other: PlaceboParticipants with the age group >= 12 to < 21 months receive placebo (normal saline), SC injection, on Day 1 and Day 90. |
| Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months) | Experimental | Biological: TDVParticipants with the age group >=6 to <12 months receive TDV, 0.5 mL SC injection, on Day 1 and Day 90. |
| Cohort 2: Placebo (Age group: >=6 to <12 months) | Experimental | Other: PlaceboParticipants with the age group >=6 to <12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90. |
Who may qualify
- Ages
- 6 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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 nature of the trial has been explained according to local regulatory requirements.
- 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.
Key exclusion criteria (29 listed)
- 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 participating country.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDVAlso: QDENGA, TAK-003TDV SC injection. | Biological | Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months), Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months) |
| PlaceboPlacebo SC injection. | Other | Cohort 1: Placebo (Age group: >=12 to <21 months), Cohort 2: Placebo (Age group: >=6 to <12 months) |
Primary outcome
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)
Time frame: Within 7 Days post-vaccination at Day 1
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)
Time frame: Within 7 days post-vaccination at Day 90
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)
Time frame: Within 14 days post-vaccination at Day 1
Solicited systemic AEs include fever (body temperature greater than or equal to [>=] 38-degree Celsius [C], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)
Time frame: Within 14 days post-vaccination at Day 90
Solicited systemic AEs include fever (body temperature >= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 1
Time frame: Within 28 days post-vaccination at Day 1
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 90
Time frame: Within 28 days post-vaccination at Day 90
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).
Percentage of Participants with Medically-attended AEs (MAAEs)
Time frame: From Day 1 through the end of trial (up to Day 1170)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: From Day 1 through the end of trial (up to Day 1170)
SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120
Time frame: Day 120
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
3 secondary outcomes
GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates for 4 Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Dengue Fever
Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director Study Director study director
Takeda
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TDV in people with Dengue Fever, run by Takeda at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity) (time frame: Within 7 Days post-vaccination at Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.