AzTrials
AzTrials

Dengue FeverPhase 3NCT07047521

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults

A Phase 3 study testing Tetravalent Dengue Vaccine (TDV) in people with Dengue Fever, run by Takeda at 5 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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 TDV in current formulation has been approved by health authorities in many countries around the world. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dengue Fever
What is being tested?
Tetravalent Dengue Vaccine (TDV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
496 participants
Where
5 sitesAustralia
Study dates
7 Nov 2025to 22 Dec 2026
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant eligibility is determined according to the following criteria:
  • Participant is aged 18 to 60 years 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, and the clinical judgment of the investigator.
  • Participant is immunologically naive to dengue, based on negative results for the detection of anti-DENV antibodies as documented by serological testing at screening.
  • Participant has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, 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 IB and/or approved product label in the participating country.
  • Participant has a known hypersensitivity or allergy to any of the Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) 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 (eg, 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:
Show all 37Show fewer
  • Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than and equal to [>=] 2 milligrams per kilograms [mg/kg] body weight/day prednisone [or equivalent] for >=14 consecutive days or >=20 mg/day prednisone [or equivalent] administered for >=14 consecutive days) within 60 days prior to Day 1 (Month [M] 0) (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. 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.
  • 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 a known previous infection with any flavivirus, including dengue, yellow fever, Japanese encephalitis, or tick-borne encephalitis viruses.
  • Participant has previous or planned (during the trial conduct) vaccination against any flavivirus, including dengue (investigational or licensed vaccine), yellow fever viruses, Japanese encephalitis, or tick-borne encephalitis.
  • Participant has a clinically significant active infection (as assessed by the investigator) or body temperature >= 38.0 degrees Celsius (°C) (>=100.4 degrees Fahrenhit [°F]) within 3 days of intended TDV 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 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 (ie, a positive or indeterminate pregnancy test).
  • Female participants who are breastfeeding.
  • Female participants of childbearing potential1 who are sexually active and who have not used any of the acceptable contraceptive methods2 for at least 2 months prior to Day 1 (M0).
  • Female participants of childbearing potential1 who are sexually active with a non-sterilized male partner and refuse to use an acceptable contraceptive method up to 6 weeks post second TDV vaccination on Day 90 (M3), or who are planning to donate ova up to 6 weeks each post first (on Day 1 [M0]) and post second (on Day 90 [M3]) TDV administration.
  • Non-sterilized male participants who are sexually active with a female partner of childbearing potential1 and refuse to use a barrier method 4 of contraception up to 6 weeks each post first (on Day 1 [M0]) and post second (on Day 90 [M3]) TDV administration, or who are planning to donate sperm during these periods.
  • Participant has received any of the following:
  • A licensed vaccine within 14 days (for inactivated or mRNA vaccines) or 28 days (for live or vector-based [if vector amplifies in body] vaccines) prior to TDV administration.
  • A vaccine authorized for emergency use within 28 days prior to TDV administration.
  • Participant is scheduled to receive any vaccine within 28 days after TDV 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, Japanese encephalitis) candidate vaccine, except if it is known that the participant received placebo in those trials.
  • Participant is planning to donate blood, organs, or tissues up to 6 weeks post second vaccination on Day 90 (M3).
  • 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.
  • Participant has lived in a dengue-endemic area for >=3 months.
  • Participant has planned travel (during trial conduct) to any endemic area for dengue and other flaviviruses.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Australia5 sites

  • Veritus Research

    Bayswater, Victoria, 3153

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2150

  • Emeritus Research Sydney

    Botany, New South Wales, 2019

  • Emeritus Research Camberwell (Melbourne)

    Camberwell, Victoria, 3124

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales, 2259

Other trials in Australia

About this study

Official title: A Randomized, Double-Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of a New Formulation of Tetravalent Dengue Vaccine (TDV) Versus the Current Formulation of TDV in Healthy Adults (Aged 18-60 Years) in a Non-Endemic Area for Dengue

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV.

Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Conditions
Dengue Fever
Being tested
Tetravalent Dengue Vaccine (TDV)
Keywords
Vaccine
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetravalent Dengue Vaccine (TDV)Biological

    Also called TAK-003

    TDV subcutaneous injection

Study groups in NCT07047521
Study groupRoleWhat they receive
Tetravalent Dengue Vaccine (TDV) (New)ExperimentalParticipants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).
Receives: Biological: Tetravalent Dengue Vaccine (TDV)
Tetravalent Dengue Vaccine (TDV) (current)ExperimentalParticipants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).
Receives: Biological: Tetravalent Dengue Vaccine (TDV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups

    GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.

    Measured: At Day 120

Secondary outcomes (7)

  1. GMTs of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 270 In the TDV (New) And TDV (Current) Groups

    GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 270 in the TDV (new) and TDV (current) groups will be reported.

    Measured: At Day 270

  2. Seropositivity Rates Against Each of the 4 Dengue Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups

    Seropositivity rate is defined the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a neutralizing 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: At Days 120 and 270

  3. Seropositivity Rates Against Multiple (2, 3 or 4) Dengue Virus Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups

    Seropositivity rate is defined the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a neutralizing 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: At Days 120 and 270

  4. Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days Post Vaccination (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 and Day 90

  5. Percentage of Participants With Solicited Systemic AEs for 14 days Post Vaccination (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 and Day 90

  6. Percentage of Participants With Any Unsolicited Adverse Events (AEs) for 28 days Post Vaccination

    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

  7. Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study

    An SAE was defined as any untoward medical occurrence or effect that 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 first vaccination (Day 1) through end of study (Day 270)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start7 Nov 2025
  3. Primary completion29 Jun 2026
  4. Study completion22 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
496 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047521
Sponsor's protocol ID
DEN-322
Status last verified
Jul 2026
First submitted
24 Jun 2025
Last updated
17 Jul 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tetravalent Dengue Vaccine (TDV) in people with Dengue Fever, run by Takeda at 5 sites in Australia.

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 7 inclusion and 37 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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?

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?

Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups (time frame: At Day 120). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07047521.

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 17 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in