Dengue Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue
The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to
assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for
dengue.
The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to
receive:
- TDV 0.5 mL subcutaneous injection
- Placebo normal saline solution (0.9% NaCl) for injection.
In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous
injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses
(8 subjects discontinued the trial before receiving the second dose).
This multi-center trial was conducted in Mexico. The overall time to participate in this
study was 270 days. Participants had multiple visits to the clinic including a final visit at
Day 270.
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