NCT02948829

Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.

Detailed description

The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions. The study enrolled 200 participants. Participants received: • TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3). This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	TDV	TDV SC injection.

Timeline

• Start date: 2017-04-03
• Primary completion: 2017-10-16
• Completion: 2020-12-14
• First posted: 2016-10-28
• Last updated: 2024-03-15
• Results posted: 2021-04-26

Locations

2 sites across 2 countries: Panama, Philippines