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New dengue vaccine trial shows promise for india

NCT ID NCT06060067

Vaccine Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested Takeda's dengue vaccine (TDV) in 480 healthy people aged 4 to 60 in India. Participants received two doses of either the vaccine or a placebo, three months apart. The main goals were to check for side effects and measure the body's immune response against all four types of dengue virus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Takeda's dengue vaccine (TDV, also called TAK-003)
What this could lead to
If successful, this vaccine could help protect people in India from dengue fever, a serious mosquito-borne disease.
What could go wrong
This is a Phase 3 trial focused on safety and immune response, not yet proven to prevent dengue in the real world. Side effects like injection site pain or fever are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

480 people

The number who actually took part.

Started

Mar 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1\. Participants who can comply with trial procedures and are available for the duration of follow-up. Key Exclusion Criteria: At screening and at vaccination: 1. A body mass index (BMI) ≥35 kg/m\^2. 2. Intent to participate in another clinical trial at any time during the conduct of this trial. 3. Plans to receive any of the following: 1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration. 2. A coronavirus vaccine within 14 days prior to TDV or placebo administration. 3. A vaccine authorized for emergency use within 28 days of TDV or placebo administration. 4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation. 5. Receipt of previous vaccination against dengue virus. 6. Previous participation in any clinical trial of a dengue candidate vaccine. At Vaccination: 1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment. 2. Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration. NOTE: Other protocol defined Inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

dengue disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri

    Bangalore, Karnataka, 560060, India

  • Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam

    Pudupākkam, Tamil Nadu, 603 103, India

  • IPGME&R and SSKM Hospital, 244 AJC Bose Road

    Kolkata, 700020, India

  • KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth

    Pune, 411011, India

  • King George Hospital

    Visakhapatnam, 530002, India

  • King George's Medical University, Department of Medicine, Chowk

    Lucknow, 226003, India

  • Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center

    New Delhi, 110002, India

  • Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar

    Bhubaneswar, 751003, India

  • SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri

    Kattankulathur, 603203, India

  • Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati

    Nashik, 422003, India

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