A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
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.
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:
- 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.
- Previous participation in any clinical trial of a dengue candidate vaccine.
At Vaccination:
- Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment.
- 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.
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.
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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