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

Launched by TAKEDA · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a dengue vaccine designed by Takeda, specifically looking at how well it works and what side effects it might cause in healthy children, teenagers, and adults in India. Participants will receive two doses of either the vaccine or a placebo (a harmless substance with no active vaccine) within three months. The study aims to see how the body’s immune system responds to the vaccine and will involve six visits to the clinic, where participants will have up to four blood samples taken.

To participate, individuals need to be able to follow the study procedures and be available for follow-up appointments. They should be between the ages of 1460 days (approximately 4 years) and 21914 days (approximately 60 years). However, some people may not be eligible if they have a high body weight, are planning to receive other vaccines shortly, or have a history of substance abuse that could affect their participation. This trial is currently recruiting participants, and it’s a great opportunity to help researchers learn more about dengue prevention.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Participants who can comply with trial procedures and are available for the duration of follow-up.
• 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.