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 range4 Years – 60 Years

SexALL

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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.
✕. Receipt of previous vaccination against dengue virus.

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

Timeframe: Within 7 days postvaccination at Day 1

Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90

Timeframe: Within 7 days postvaccination at Day 90

Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1

Timeframe: Within 14 days postvaccination at Day 1

Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90

Timeframe: Within 14 days postvaccination at Day 90

Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1

Timeframe: Within 28 days postvaccination at Day 1

Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90

Timeframe: Within 28 days postvaccination at Day 90

Percentage of Participants with an AE Leading to Participant Withdrawal from Trial

Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)

Trial details

NCT IDNCT06060067

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-05

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