Status:
COMPLETED
A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
4-60 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants. Th...
Eligibility Criteria
Inclusion
- Key
- 1\. Participants who can comply with trial procedures and are available for the duration of follow-up.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
March 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT06060067
Start Date
March 29 2024
End Date
May 5 2025
Last Update
November 26 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri
Bangalore, Karnataka, India, 560060
2
Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam
Pudupākkam, Tamil Nadu, India, 603 103
3
Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar
Bhubaneshwar, India, 751003
4
SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri
Kattankulathur, India, 603203