For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

1. Participants who can comply with trial procedures and are available for the duration of follow-up.

EXCLUSION CRITERIA

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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-877-825-3327Email iconEmail Study Center

Study Details


Contition

Healthy Volunteers

Age

4 - 60

Phase

PHASE3

Participants Needed

480

Est. Completion Date

Apr 1, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Takeda

ClinicalTrials.gov NCT Identifier

NCT06060067

Study Number

DEN-302

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