CompletedPhase 3

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

India480 participantsStarted 2024-03-29

Plain-language summary

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.

Who can participate

Age range

4 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. A body mass index (BMI) ≥35 kg/m\^2.
. Intent to participate in another clinical trial at any time during the conduct of this trial.
. Plans to receive 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.
. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
. A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

Timeframe: Within 7 days post-vaccination at Day 1

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over

Timeframe: Within 7 days post-vaccination at Day 1

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years

Timeframe: Within 7 days post-vaccination at Day 90

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over

Timeframe: Within 7 days post-vaccination at Day 90

Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

Timeframe: Within 14 days post-vaccination at Day 1

Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over

Trial details

NCT IDNCT06060067

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-05

Results submitted2026-05-04

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range

4 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. A body mass index (BMI) ≥35 kg/m\^2.
. Intent to participate in another clinical trial at any time during the conduct of this trial.
. Plans to receive 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.
. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
. A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.

What they're measuring

Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

Timeframe: Within 7 days post-vaccination at Day 1

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over

Timeframe: Within 7 days post-vaccination at Day 1

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years

Timeframe: Within 7 days post-vaccination at Day 90

Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over

Timeframe: Within 7 days post-vaccination at Day 90

Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

Timeframe: Within 14 days post-vaccination at Day 1

Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over