Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06060067
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 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.
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.
The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study:
* Cohort 1, ≥18 to ≤60 Age Group: TDV
* Cohort 1, ≥18 to ≤60 Age Group: Placebo
* Cohort 2, ≥4 to \<18 Age Group: TDV
* Cohort 2, ≥4 to \<18 Age Group: Placebo
This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.
Study:
NCT06060067
Study Brief:
Protocol Section:
NCT06060067