Dengue FeverPhase 3NCT06579755
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
A Phase 3 study testing TDV in people with Dengue Fever, run by Takeda at 7 sites in 4 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. Researchers have seen that dengue fever now also happens more often in elderly persons. Read more about this study
- Who is it for?
- Ages 45 to 79 yearsHealthy 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
- 800 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 20 Jan 2026to 14 Apr 2027
- 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 45 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is aged 45 to 79 years at the time of entry into the trial.
- Participant is male or female.
- Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
- Participant has signed and dated a written informed consent form 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.
- Participant can comply with trial procedures and is available for the duration of follow-up.
Who cannot join
- Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure and/or approved product label (as applicable) in the participating country.
- Participant has a known hypersensitivity or allergy to any of the TDV or placebo components (including excipients).
- Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part 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 altered immunocompetence, including:
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- Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than or equal to [>=] 2 milligram per kilogram [mg/kg] body weight prednisone [or equivalent] for >=14 consecutive days, or >=20 milligram per day [mg/day] prednisone [or equivalent] administered for >=14 consecutive days) within 60 days prior to Day 1 (month [M0]) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
- Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
- 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).
- Human Immunodeficiency Virus (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 had a clinically significant active infection (as assessed by the investigator) or body temperature >38.0 degree Celsius (>100.4 degree Fahrenheit) within 3 days of intended TDV or placebo administration.
- 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 the last use of antipyretics and/or analgesic medications.
- Participant has a history of substance or alcohol abuse within the past 2 years.
- Female participants who are pregnant (that is, a positive or indeterminate pregnancy test).
- Female participants who are breastfeeding.
- Female participants of childbearing potential who are sexually active and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).
- Female participants of childbearing potential who are sexually active and who refuse to use an acceptable contraceptive method up to 6 weeks post final vaccination on Day 90 (M3). In addition, they must also be advised not to donate ova during this period.
- Participant has received any of the following:
- A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration on Day 1 (M0). This includes co-administration with routine vaccines.
- A coronavirus vaccine within 14 days prior to TDV or placebo administration.
- A vaccine authorized for emergency use within 28 days prior to TDV or placebo administration.
- Participant is scheduled to receive any other vaccine within 28 days after TDV or placebo administration.
- Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intending 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 those trials.
- Participant or their first-degree relatives are involved in the trial conduct.
- Participant identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Brazil2 sites
Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
Salvador, Estado de Bahia, 40444-130
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, 15090-000
Singapore2 sites
Singapore General Hospital (SGH)
Singapore, 169608
Tan Tock Seng Hospital
Singapore, 308433
Thailand2 sites
Ramathibodi Hospital
Ratchathewi, Bangkok, 10400
Hospital for Tropical Diseases
Ratchathewi, Krung Thep Maha Nakhon-Bangkok, 10400
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults, Aged >60 to 79 Years) and Open-Label (Adults, Aged 45 to 60 Years), Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (TDV) Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.
In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).
During the study, participants will visit their study clinic 5 times.
- Conditions
- Dengue Fever
- Being tested
- TDV, Placebo
- Keywords
- Vaccination
- 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 TAK-003
TDV SC injection.
PlaceboOther
Placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL | Experimental | Participants with the age group greater than (>) 60 to 79 years will receive TDV, 0.5 mL subcutaneous (SC) injections, on Day 1 and Day 90. Receives: Biological: TDV |
| Cohort 1: Placebo | Placebo comparator | Participants with the age group >60 to 79 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90. Receives: Other: Placebo |
| Cohort 2: TDV 0.5 mL | Experimental | Participants with the age group 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90. Receives: Biological: TDV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. 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.
Measured: Within 7 days post-vaccination at Day 1
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) 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.
Measured: Within 7 days post-vaccination at Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
Solicited systemic AEs include fever (body temperature greater than or equal to [>=] 38 degree Celsius [C], asthenia, malaise, headache, and myalgia.
Measured: Within 14 days post-vaccination at Day 1
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia.
Measured: Within 14 days post-vaccination at Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity 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 will be graded by investigator as Grade 0: none, 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 by Severity 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 will be graded by investigator as Grade 0: none, 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 by Severity Within 14 Days Post Vaccination at Day 1
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, 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 by Severity Within 14 Days Post Vaccination at Day 90
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 14 days post-vaccination at Day 90
Percentage of Participants with Any 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 Any 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 a Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
Measured: From first vaccination on Day 1 through the end of trial (up to Day 270)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
Measured: At Day 120
Secondary outcomes (12)
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
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.
Measured: Within 7 days post-vaccination at Day 1 and Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia.
Measured: Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
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 will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 7 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities)
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Measured: Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination (With Comorbidities)
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 and Day 90
Percentage of Participants with a SAE (With Comorbidities)
An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
Measured: From first vaccination on Day 1 through the end of trial (up to Day 270)
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 90 and Day 270
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes
Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against each of the four dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against each of the four dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes
Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against multiple (2, 3, or 4) dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes (With Comorbidities)
Seropositivity rate is defined as 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 90, Day 120 and Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start20 Jan 2026
- Primary completion14 Apr 2027 (estimated)
- Study completion14 Apr 2027 (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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579755
- Sponsor's protocol ID
- DEN-321
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2024
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults, Aged >60 to 79 Years) and Open-Label (Adults, Aged 45 to 60 Years), Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (TDV) Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue
- ClinicalTrials.gov ID
- NCT06579755
- Acronym / sponsor ID
- DEN-321
- Conditions
- Dengue Fever
- Keywords
- Vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 30 Aug 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. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.
In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).
During the study, participants will visit their study clinic 5 times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL | Experimental | Biological: TDVParticipants with the age group greater than (>) 60 to 79 years will receive TDV, 0.5 mL subcutaneous (SC) injections, on Day 1 and Day 90. |
| Cohort 1: Placebo | Placebo comparator | Other: PlaceboParticipants with the age group >60 to 79 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90. |
| Cohort 2: TDV 0.5 mL | Experimental | Biological: TDVParticipants with the age group 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is aged 45 to 79 years at the time of entry into the trial.
- Participant is male or female.
- Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
- Participant has signed and dated a written informed consent form 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.
- Participant can comply with trial procedures and is available for the duration of follow-up.
Key exclusion criteria (34 listed)
- Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure and/or approved product label (as applicable) in the participating country.
- Participant has a known hypersensitivity or allergy to any of the TDV or placebo components (including excipients).
- Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part 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.
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: TAK-003TDV SC injection. | Biological | Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL, Cohort 2: TDV 0.5 mL |
| PlaceboPlacebo SC injection. | Other | Cohort 1: Placebo |
Primary outcome
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
Time frame: Within 7 days post-vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. 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.
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90
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.
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
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], asthenia, malaise, headache, and myalgia.
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
Time frame: Within 14 days post-vaccination at Day 90
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia.
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1
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 will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90
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 will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
Time frame: Within 14 days post-vaccination at Day 1
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90
Time frame: Within 14 days post-vaccination at Day 90
Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Any 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 Any 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 a Serious Adverse Event (SAE)
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120
Time frame: At Day 120
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
12 secondary outcomes
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Time frame: Within 7 days post-vaccination at Day 1 and Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Time frame: Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Time frame: Within 7 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities)
Time frame: Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination (With Comorbidities)
Time frame: Within 28 days post-vaccination at Day 1 and Day 90
Percentage of Participants with a SAE (With Comorbidities)
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 90 and Day 270
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes (With Comorbidities)
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
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 22 Sep 2026.
- 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.
- 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.
- 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.
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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. This study is not recruiting at the moment.
Study Director study director
Takeda
7 sites in 4 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 7 sites in 4 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 5 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil, Singapore, Thailand, Argentina. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (time frame: Within 7 days post-vaccination at Day 1). The study lists 12 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 22 Sep 2026.